chison medical imaging co. ltd. 510(k) submissochison medical imaging co., ltd. 510(k) submission...

JUN 0'22014 pay-~ 4Chison Medical Imaging Co. Ltd. 510(K) Submisso

510(k) Summary

This Summary of 510 (K) Safety and Effectiveness information is being submitted in accordance withthe requirements of SMVDA 1990 and 21 CFR Part 807.92.

The assigned 510(K) number: K140364

1. Date of submission : January 12, 2014

2. Submitter:Chison Medical Imaging Co., Ltd.No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142

Contact: Ms. Ruoli MoTel1: +86-510-85311707, 85310593 Fax: +86-510-85310726U.S. Agent: Leiker Regulatory & Quality Consulting

7263 Cronin CircleDublin, CA 94568

Contact: Bob LeikerTel: (925) 719-1946 Fax: (866) 718-3819

3. Proposed Device Identification:Trade/Proprietary: Q Series & i7,i8, i9 Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System with Accessories

Classification: Regulatory Class: 11Review Category: Tier 11

Classfication Name 21 CFR Section Product CodeUltrasonic pulsed dloppler imaging system 892.1550 90S-IYNUltrasonic pulsed echo imaging system 892.1560 90-IYGDiagnostic ultrasonic transducer 892.1570 90-ITX

4. Legally Marketed Predicate Device:K1 01236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound SystemK120801 CHISON iVis6OEXPERT, Q6/Q8, i7 Diagnostic Ultrasound Systems

5. Device Description:

510(k) Summary of 11

Chison Medical Imaging Co., Ltd. 510(K) Submission

The Q6IQ8IQ9IQ1O/i7/i8 /i9 ultrasound system is an integrated preprogrammed color dopplerultrasound imaging system, capable of producing high detail resolution intended for clinicaldiagnostic imaging applications.The CHISON ultrasound system can be configured either as a portable model (Q6IQB/Q9IQ1O),or as a roll-around model on wheels (i7/iBi9). These systems are designed with the latesttechnology, using the same quality procedure as ultrasound systems which have been availablein the market for years.

This CHISON ultrasound system is a general purpose, software control led, diagnostic ultrasound*system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode(including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW)Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDIMode or a combination of these modes.3D/4D.

6. Indications for Use:The device is a general-purpose ultrasonic imaging instrument intended for use by a qualifiedphysician for evaluation of Fetal/OB3; Abdominal (GYN & Urology); Pediatric; Small Organ(breast,testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); PeripheralVascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

7. Summary of Modifications and Newly Added FeaturesThe Q Series & 7, i8, i9 Diagnostic Ultrasound System employs the same technology as thepredicate devices. This submission device is a modification to CHISON iVis6OEXPERT,Q6 /Q8,7 Diagnostic Ultrasound Systems previously cleared in K(120801. The submission device alsohas the same intended uses and basic operating modes as the predicate devices.The following is a brief overview of the modifications and newly added features. Detailedinformation is found in Section 1_-4 General Device Description of this submission, while Section1 5 Predicate Device Comparison to Legally Marketed Device includes a discussion ofsubstantial equivalence with the predicate device(s).Newly added transducers:D3C6OL-BDSC6OL-CD7L4OL-CD12L4OLD7C1 0[-CV6C1OLD5C2OL-AD3C2OL

D6C1 5L-AD2D16L


Chison Medical Imaging Co., Ltd. 510(K) Submission

V4C4OL-CNewly added software options:2D SteerElastographyCurved Panoramic ImagingSupper needleIMT Auto IMT measurementvascular measurement packagesmall parts measurement packagePediatric measurement packageAll of the above modifications have been compared with the predicate devices. The results showthat these modifications are substantially equivalent to the predicate devices.

8. Testing:Laboratory testing was conducted to verify that the 530 system with added transducer met all

design specification and was substantially equivalent to the Predicate Device.The device has been found to conform to applicable medical device safety standards in regardsto thermal, mechanical and electrical safety as well as biocompatibility.lEG 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for SafetylEG 60601-1 -2: 2007 Medical Electrical Equipment - Padt 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.lEG 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for thebasic safety and essential performance of ultrasonic medical diagnostic and monitoringequipment.NEMA UID 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentVersion 3.NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic OutputIndices on Diagnostic Ultrasound EquipmentISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within arisk management process

9. Clinical Test:No clinical testing was required.

10. Comparison to Predicate Device:

Table 1 Substantial Equivalence Comparison

51 0(k) Summary of 11

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Chison Medical Imaging Co.. Ltd. 510(K) Submission

Comparison Analysis

SE Analysis 1The Operating Controls item of proposed device and the predicate deviceare with different Image Reverse/Frequency Selection/AngleCorrection/Steered Linear/Color Maps/PD Color Maps, but they can beconsidered Substantially Equivalent in safety and effectiveness. So the SEis not affected.

SE Analysis 2The screen size of the proposed is smaller than that of the ES. Thisdifference is considered to have no effect on effectiveness and safety.

SE Analysis 3The Transducer Connectors of the proposed is less than that of the E8. Thisdifference is considered to have no effect on effectiveness and safety.

SE Analysis 4The Power Supply of the proposed device and the predicate device are AC:1bOy- 240V and AC: 220V - 240V; 100OV, 11 5V- 130 V respectively, but both ofthem comply with IEC60601-1 and IEC 60601-1-2. Therefore, power supplycan be considered Substantially Equivalent in safety and effectiveness.

Discussion of Substantially EquivalentThe subject device has same intended use, same product design, sameperformance effectiveness, and performance safety as the predicatedevice. The differences above between the subject device and predicatedevice do not affect the basic design principle, usage, effectiveness andsafety of the subject device.

11. Substantially Equivalent Conclusion:I n accordance with the Federal Food Drug and Cosmetic Act. 21 CERPart 807 and based on the information provided in this premarketnotification, Chison Medical Imaging Co., Ltd. concludes that theCHISON Q Series and i7, i8, i9 Diagnostic Ultrasound System issubstantially equivalent to predicate devices with regard to safety andeffectiveness.


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

.4 10903 New Hampshire Avenuec

June 2, 2014Chison Medical Imaging Co., Ltd.% Mr. Bob LeikerLeiker Regulatory & Quality7263 Cronin CircleDUBLIN CA 94568

Re: K140364Trade/Device Name: Q Series & i7, i8, i9 Diagnostic Ultrasound SystemRegulation Number: 21 CER 892.1550Regulation Name: Ultrasonic pulsed doppler imaging systemRegulatory Class: 11Product Code: IYN, IYO, ITXDated: April 15, 2014Received: April IS, 2014

Dear Mr. Leiker:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended foruse with the Q Series & i7, i8, i9 Diagnostic Ultrasound System, as described in your premarketnotification:

Transducer Model Number

D3C6OL, Convex Array D3C6OL-B, Convex ArrayD3C6OL-C, Convex Array D7L4OL, Linear ArrayD7L4OL-C, Linear Array D7L6OL, Linear ArrayD I2L4OL, Linear Array D7L3OL, Linear ArrayD6CI2L, Micro Convex Array D7C IOL, Micro Convex ArrayD7C IOL-C, Micro Convex Array V6C IOL, Volume ProbeDSC2OL, Micro Convex Array D5C2OL-A, Micro Convex ArrayD3C2OL, Micro Convex Array D6CIS5L, Micro Convex ArrayD6CISL-A, Micro Convex Array D3P64L, Phased Array

Mr. Leiker

D6P64L, Phased Array D2DI6L, Pencil ArrayV4C4OL, Volume probe V4C4OL-C, Volume Probe

If your device is classified (see above) into either class!!1 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21I CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041or (301) 796-7100 or at its Internet addresshttp)://www.fda.gov/Medical Devices/ResourcesforYou/Industrv/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (2 ICFR Part 803), please go tohttp://www.fda.gov/MedicalDevices/Saft/ReportaProblem/default.html for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet addresshttr)://www.fdasgov/Medica] Devices[ResourcesforYou/lndustrv/default.htm.

Sincerely yours,

forJanine M. MorrisDirectorDivision of Radiological HealthOffice of In Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

510(k) Number (if known)

K140364

Device NameQ Series & i7, iS, i9 Diagnostic Ultrasound Systems

Indications for Use (Describe)The device is a general-purpose ultrasonic imaging instument intended for use by a qualified physician for evaluation ofrretal/OB:Abdomninal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid): Cardiac (adult & pediatric); Peripheral Vascular,Musculo-skeletal Conventional & Superficial, Tranisvginal.

Type of Use (Select one or both. as applicable)

SPrescription Use (Part 21 CFR 801 Subpart 0) E0 Over-The-Countier Use (21 CFR 801 Subpart C)

PLEASE DO. NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signatures)

FORM FDA 3881 (1114) Pop, 1 of 24 Ia.Swioui H

Chison Medical Imaging Co.. Lid. C Series & V?. ill, i9 Diagnostic Ultrasound Systems

Diagnostic Ultrasound Indications For Use

System: Q6/08/OQ 10, i7/i8/19 Diagnostic Ultrasound Systems

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of 0peration _________

General specific B M PW CW Color Power Combined Hlarmonic Other(Track I Only) (Tracks I & 3) B M Dopple Dopi Doppler Dopple Modes Imaging

Ophthalmic Ophthalmic _________

Fetal Imaging& Fetal P P P P P P P 3,5Other Abdominal P P P P P P P 3,4,5

Intre-operative(Specify) ___ ______ ____ ____

Intra-operative (Neuro) _________

Laparoscopic __________

Pediatric P I p P P P P 4.5Small Organ"' (Specify) P p p P P p p 4.5Neonatal Cephalic ____ _____

Adult Cephalic __ _____

Truns-rectal _____ _____

Trans-vaginal p p P p p p P 3.4.5

Truns-urethral ___________

Trans-esoph. (non-Card.)Musculo-skeletal P p p p P P P 4.5(Conventional) I__________

Musculo-skeletal p Ip P p P P p 4,(Superficiali____ ____

Other (Urology) p p P p p P P 4,5

Other (Ob/GYN) P P PPPP p p 5

CricCardiac Adult P p p P P P PP 5_______Cardiac Pediatric P P p p p p ppPe ea eslPeripheral vessel P P p p P P p I p # 5q

N =new indication; P = previously cleared by FDA; E - added under this appendix

Note: :1. Combined modes are B/M. B+-PWD. B/Color M, B/PWD or CWD. 1/Color/PWD or CWD.B/Power/PWD2.Small Organ: Breast, testes, thyroid3.3 DI4D Imaging Mode4.El1astography imaging5. Includes imaging of guidance of biopsy (Super needle)

Prescription Use >( AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) -(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)Division of Radiological Health

Office of In Vitro Diagnostic and Radiological Health5 1 0(k)

Section 1.3 indications For Use Page 2 of 24

Chison Medical Imaging Co., Ltd. C Series & 17,1il, 1S Diagnostic Ultrasound Systems

System: Q6108/Q9/Q1O, i7/18/19 Diagnostic Ultrasound SystemsTransducer: D3C6CL, Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application ____ Mode of Operation ____ __

General Specific B M PW CW Color Power Combined Harmonic Other(Track I Only) (Tracks I & 3) 13 M Doppler 22ppr Doppler Dopplej Modes Imaging

Ophthalmic Ophthalmic _____

FetallImaging & Fetal P P P P P P P 5Other Abdominal P P P p p p p 4,5

Intira-perative(Specify)Intra-operative (Neuro)II IILaparoscopicPediatricSmall Organ" (Speify

coaa ehalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.) ___

Musculo-skeletal(Conventional) ___ - - -

Musculo-skeletal(Superficial)Other (Urology) P - - P 4.

Ot_____ her (Ob/G VN) P PP P P PP P

Cardiac Cardiac Adult ____ _____

______________Cardiac Pediatric ____ _____

[Peripheral Vessel Peripheral vessel ____ _____

N = new indication; P = previously cleared by FDA; E =added under this appendix

Note: 1. Combined modes arm BIM, B+PWD. B/Color M, B/PWD or CWD. B/ColorIPWD or CWD,B/Powcr/PWD2.Small Organ: Breast, testes, thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy

Prescription Use X AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)




Seclon 1.3 Indications For Use Page 3 of 24

Chison Medical Imaging Co.. Ltd. 0 Series & 17. iW, is Diagnostic Ultrasound Systems

System: 061081Q91010, i7fi~fi9 Diagnostic Ultrasound Systems

Transducer: D3C6OLt'B, Convex Array


Clinical Application Mode oro Oeration

General Specific PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler Doppler Doppljr Doppler Modes Imaging Ote

Ophthalmic OphthalmicFetal lmaging& Petal N N N N N IN N 5Other Abdominal N N N N N N N .3

I ntra-operative(specify) ____

Intra-operative (Neuro) I____

lapaosopic _____ ________

Small Organ"'( Specify) ____

Neonatal CcphalicAdult CephalicTranis-rectal ____ ___

Trans-vaginalTrans-urethralTrans-esoph. (non-

Card.)--------------------------Musculo-skeletal(Conventional)_____

Musculo-skeletal(Superficial)Other (UrologNyN) N N N N 4.5

________Other (Ob/GYN) N I N N N N 5

CardiacCardiac Adult_____________Cardiac Pediatric

Periherl VeselPeripheral vessel ____

N =new indication; P = previously cleared by FDA: E added under this appendix

Note: 1. Combined modes arc B/M. B+PWD. B/Color M. B/l'WD or CWD. B/Color/PWD or CWD).B/Powvcr/PWD2.Small Organ: Breast, testes, thyroid3.3D/41" Imaging Mode4.Llaslogntphy imaging5. Includes imaging of guidance or' biopsy

Predicate transducer (K number); K 101236, K 120801

Prescription Use X AND/ORk Over-The-Counter Use __ _

(Part 21 CER 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign Of)Division of Radiological Health

office of In Vitro Diagnostic and Radiological Health5 1 0(k)

Section 1.3 indications For Use Page 40of24

Chison Medical Imaging Co., Ltd. 0 Series & 17. i8.9i Diagnostic Ultrasound Systems

System: 06/08/09/0 10, 17/18/19 Diagnostic Ultrasound Systems

Transducer: 03C60L-C, Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0aeration

(Track I Only) (Tracks I & 3) B M OtheolrPwerobie aroiGeneralEpI Speifile Doppler Doppler Modes Imaging Ote

Ophthalmic Ophthalmic ___ ____

FetallImaging & Fetal N N N ___ N N N N 5Other Abdominal N N N ___ N N N N 4,5

Intra-operative(Specify) ____ ____

Intra-operative (Neuro) _____

Laparoscopic ___

PediatricSmall Organ"'l (specify) ____

Neonatal Cephalic ___ ____ ____

Adult Cephalic ____

Trants-rectalTrams-vagi nalTrans-urethralTrans-esoph. (non-Card.)

Musculo-skeletal(ConventionlMusculo-skeletal(Superficial) _________

Other (Urology) N N N N N N N 4.5_________Other (Ob/GYN) N IN N N N 5

Cardiac Card iac dut ____

_____________Cardiac Pediatric ____

Periherl Veselperipheral vessel ___________

N - new indication; P = previously cleared by FDA; E - added under this appendixNote: 1. Combined modes arc B/M, B+PWD, B/Color M. B/PWD or CWD, B/Color/PWD or CWD,B/Powvcr/PWD

2.Small Organ: Breast, testes, thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging of guidance or biopsy

Predicate transducer(K number): K101236. K4120801



Concurrence ofCCDRHl Office of Device Evaluation (ODE)

(Division Sign Oft)Division of Radiological Health


Section 1.3 indications For use Page 5 of 24

Chison Medical Imaging Co., Ltd. 0 Series & 17,.18.11? Diagnostic untrsound System

System: 06/Q8/09/O i7fi8/i9 Diagnostic Ultrasound Systems

Transducer: D7L-4OL-, Linear Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of Operation _________

General Specific B ri PW CW Color power Combined HarmonicOte(Track I Only) (Iracks I & 3) Doppler Ioppler Doppler loppler Modes Imaging

Ophthalmic Ophthalmic ___ ____ _____

Petal Imaging & FetalOther Abdominal

Intra-operative(specify)Intrit-operative (Neuro)I

apamoscapicPediatric P p p p P P 4,3Small Organ"r(-S-pciiV) P P P P P P P 4.5

eonatal Cephalic ____

dult Cephalic ____ _____

runs-rectalruns-vaginal ____

Truns-urethralTrans-esoph. (non-

Card.) _ _

Musculo-skecletal p p p P, p p P 4,5(Conventional) ____

Musculo-skeletal N N N N N IN N 4.3(Superficial)Other (Urology) _____

___________Other (Ob/GYN)


______________Cardiac Pediatric ____ _____

erheaVeslPeripheral vessel IP IP P p p P p5

N =new indication; P - previously cleared by FDA: E3 - added under this appendixNote: 1, Combined modes are B/M. B+PWI). B/Color M. I3/PWD or CWI). fl/Color/PWI) or CWD.B/Power/PWD

2.Small Organ; Breast, testes. thyroid3.3D/41) Imaging Mode4,Fiastography imaging5. Includes imaging of guidance of biopsy (Super needle)

Prescription Use X AND/ORk Over-The-Counter Use - -___

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONITINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRHK Office of Device Evaluation (ODE)



Section 1.3 indications For Use PageS6 of 24

Chison Medical Imaging Co.. Ltd. C Series & 17, il8. i9 Diagnostic Ultrasound Systems

System: Q6/QSIQ9IQ1O, i7/18/19 Diagnostic Ultrasound Systems

Transducer: D7L4OL-C, Linear Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0 peration ____

General Specific PW CW Color Power Combined Harmonic(Track I Only) (Tracks I & 3) B M Dpl ole opeDale Mds Imaging Other

Ophthalmic OphthalmicFetal Imaging & FetalOther Abdominal

Intra-operative(Specify) ___ ____ ____

Inut-operative (Neuro) I______ ________

La pa rosc op icPediatric N N N N N N N 4.5Small Organ"(Speciry N N N N N N N 4.5Neonatal Cephalic ____ _____

Adult Cephalic ____ _____

Trans-rectalTrans-vaginfalTrans-urethralTrans-esoph. (non-

Card.) _______

Musculo-skeletalN N NN NNN 4,(Conventional) N____ N IN IN NN N 4,

Musculo-skeletal N N IN N N N N 4.5(Superficial)Other (Urology)

__________Other (Ob/GYN) __________


______________Cardiac PediatriclPeripheral Vessel Peripheral vessel N N N NIN = new indication; P - previously cleared by FDA: E - added under this appendixNote: 1. Combined modcs arc B/M, B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD,B/Powcr/PWD

2.Small Organ: Breast, testes, thyroid3.3D/4D imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy (Super needle)

Predicate transducer (K number): K 10 1236. K 120801

Prescription Use X AND/ORk Over-The-Counter Use ___





Section 1.3 Indications For Use Page 7 of124

Chison Medical Imaging Co.. Ltd. 0 Series & 17. il. a) Diagnostic Ultrasound Systems

System: 061081091Q10, i7fi8/19 Diagnostic Uhtrasound Systems

Transducer: D7L6OL, Linear Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0peration

General Specific B M PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler QDopl Doppler Doppler Modes Imaging Ote

Ophthalmic Ophthalmic ___

Fetal Imaging & FetalOther Abdominal

Intrat-operative(Specify)Intm-operative (Neuro)

Pediatric p p p p p p p 4,5Small Organ"-(Specify) p p p p p p3 p 4,5Neonatal Cephalic ____ _____


Trans-rectal _____ _____

Trans-vaginalTrans-urethral _____

Trans-esoph. (non-Card.) _____________

Musculo-skeletal p p p p P p 45(Conventional)_____Musculo-skeletal N N N N N N N 4.5(Superficial) _________

Other (Urology) _ ______

__________Other (Ob/OYh)

kardiac Cardiac Adult ____

I_______ lCardiac Pediatric I____ ____

Pecripheral Vessel Peiripheral vessel I P p, p p P I P 5

N - new indication; P = previously cleared by FDA; E =added under this appendixNote: 1. Combined modes arc BIM, B+PWD. B/Color M. BIPWD or CWD. B/Color/PWD or CWD.B/PowcrIPWD

2.Small Organ: Breast, testes, thyroid3.3 W'$D Imaging Mode4.Elasiography imaging5. Includes imaging of guidance or biopsy (Super needle)


(Part 21 CERS801 Subpart D) (21 CFRB07 SubpartC)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign Off)Division or Radiological Health


Section 1.3 Indlcattoms For use Page 8Sof 24

Chison Medical Imaging Co., Ltd. C Series & V7, is. i9 Diagnostic Ultrasound Systems

System: 06/08/09/Q 10, W7II)1 Diagnostic Ultrasound SystemsTransducer: D1 2L-40L, Linear Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0penulion _________

General Specific PW CW Color Power Combined Harmonic(TakIOnly) (Tracks I & 3) B M .opeDpl ope Dpl oe mgn Other

Ophthalmic OphthalmicPetal Imaging & FetalOther Abdominal

Intra-operative(Specify) __________

Intina-operative (Neuro) _____________

LaparoscopiePediatric N N N N N N N 4.5Small Organ"T(S-pecify) IN N N N N N N 4.5Neonatal Cephalic ____ _____


mrns-rcial _____

Trans-vagi nalinans-urethral

Trans-esoph. (non-Card.) ____ __

Musculo-skeletal N N N N N N IN 4,5(Conventional) ____ _____

Musculo-skeletal N N N N N N N 4.5(Superficial) _________

Other (Urology) ____

__________Other (Ob/GYN) _ ______

Cardiac Cardiac Adult _____ ________

______________Cardiac Pediatric _____

lPeripheral Vessel Peripheral vessel IN N N N IN I N N 5

N = new indication; P = previously cleared by FDA: E added under this appendixNote: 1. Combined modes are 13/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/P WI or CWD.B/Power/P WI

2,SmalI Organ: Breast, testes, thyroid3,3D/413 imaging Mode4.Elasiography imaging5. Includes imaging of guidance of biopsy (Super needle)

Predicate transducer (K number): K101236

Prescription Use )< AND/ORk Over-The-Counter Use ___





Section 1.3 indications For Use Page 90124

Chison Medical Imaging Co., Ltd. C Series & i7,II.1i9 Diagnostic Ultrasound Systems

System: 061Q81091010,. 1711819 Diagnostic Ultrasound SystemsTransducer: D7L-3OL. Linear Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application ____Mode of 0 eratlon _________

(T nraIOly (tr ifc I &3 PW CW Color Power Combined HarmonicGnrackIOly SpeciackI B M) Dppe~ !plr Dple Doppler Modes Imaging Other


eta!l Imaging & FetalOther Abdomninal

I nti-operative(specify) ____ ____

Intra-operative (Neuro)LaparoscopicPediatricSmall Organ" 1 Specify N N N N N N N 4.5Neonatal Cephalic

Adult Cephfalic _____

Trans-rectalTrans-vagi nalTran s-u rethralITrans-esoph. (non-

Card.)Musculo-skeletal p p p p, P P P 4,5(Conventional) ____ ___

Musculo-skeletal p P P P4.(Superficial) ______ ______ __4.5

O0ther (Urology) __ __ _______

Cardiac Cardiac Adult ___ ____ ____

_____________Cardiac Pediatric _____________

epheral Vessel Peripheral vessel IN N N [Nih N IN N # :::N = new indication; P = previously cleared by FDA: Em= added under this appendixNote: 1. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/ower/PWD

2.Small Organ: Breast. testes, thyroid3.31)141 Imaging Mode4.F.Iastography imaging5. Includes imaging or'guidance or biopsy (Super needle)



Concurrence of CDR.H, Office of Device Evaluation (ODE)


Office of' In Vitro Diagnostic and Radiological Health5 1 0(k)

Section 1.3 indications For Use Page 10 of 24

Chison Medical Imaging Co., Ltd. Q Seiles & 17, 18.19 Diagnostic Ultrasound Systems

System: 06/08/09/0 10, 17/18/19 Diagnostic Uhtrasound Systems

Transducer: DBC1I2L, Micro Convex Array


Clinical Application Md fprto

General Specific PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler Doppler Dopple Doppler Modes Imaging Ote


Intra-operative(spedify) ___

Intro-Operi~ve (Neuro) ___ ____

LaparoscopicPediatricSmall Organ"'(Speify)___ ______ ________

Neonatal Cephalic _________

Adull CephalicTrans-rectal _____ _____

Trans-vaginal P P P p p Pp 4.5Tran s-u ret h ral ______

Trans-esoph. (non-Card.)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial) ____

__e__ (Urology p p p p p p p 45

______ ther (Ob/GYN) ___ p_ _ p P P Pp

ICardiac CrI ac A dul ' 1 1 1 -

___________Cardiac Pediatric I____ ____

eripheral Vessel Pe'ripheral vessel I I I I______

N = new indication; P = previously cleared by FDA; E =added under this appendixNote: 1. Conmbined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWJ) or CWD,BlPower/PWD

2.Small Organ: Breast, testes, thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging of guidance or biopsy

Prescription Use >C AND/OR Over-The-Counter Use ___






Chison Medical Imaging Co.. Lid. Q Series & i7, i8,19 Diagnostic Ultrasound Systems

System: 06/Q81Q91010, i71i8119 Diagnostic Ultrasound Systems

Transducer: D7C1 OL, Micro Convex Array


Clinical Application Mode of 0 eration ____

General Specific PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler Doppler Doppler Dopple Modes Imaging Other


Intra-operalive(Sped ily) ____

Intra-operative (Neuro) I____ I____

LaparoscopicPediatricSmall Organ"i' (specify)Neonatal CephalicAdult CephalicTran s-recta ITranis-vaginal P P p p p p p 4,5Trans-urethralTransesph (non-

Card.) ____

Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)Other (Urology) P p p p p p p 4.5Other(ObIGYN) P p p p p pp 5

Cdiac lCardiac AdultI________ ICardiac PediatriclPeripheral Vessel jPeripheral vessel I I IN = new indication; P =previously cleared by FDA: E added under this appendixNote: 1. Combined modes are BIM, B+PWD. B/Color M. BIPWD or CWD. B/Color/PWD or CWD.B/P'ower/PWD

2.Small Organ: Breast, testes. thyroid3.30/41) Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy





Office of In Vitro Diagnostic and Radiological Health5 10(k)


Chison Medical Imaging Co., Ltd. 0 Series & 17, 18,1if Diagnostic Ultrasound Systems

System: Q6IQOIQO/Q1O, 17/1i8/i9 Diagnostic Ultrasound SystemsTransducer: D7C 1OL-C, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of Operation _________

General Specific PW CW Color Power Combined Harmonic(T rack I Only) (Tracks I & 3) B M Doppler Doppler DooIr Doppler Modes Imaging Ote


Intra-operative(Specify)Intra-operative (Neuro)La pa roscop icPediatricSmall Organ"(S ciry)_______Neonatal Cephalic

AdultI Cephalicrs-rctal

Trans-vaginal N N N N N N N 4,5Trans-urethralTrans-esoph. (non-

Card.)I IMusculo-skeletal(Conventional)

-Musculo-skeletal

(Superficial)Other (Urology) N N N N N N N 4,5

*Other (Ob/GYN) N N N N N N N 5ICardiac Cardiac Adult

Cardiac Pediatric IPe hra VsslPeripheral vessel I I I I_______

N =new indication; P = previously cleared by FDA; 13 added under this appendixNote: 1. Combined modes are B/M. B+PWD. B/Color Mv. B/PWD or CWI). B/Color/PWD or CWD.B/Power/PWD

2.SmalI Organ: Breast, testes, thyroid3.3D/41) Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy

Predicate transducer (K number): K 10 1236. K 120801


(Part 21 CFR 801 Subpart 0) (21 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)




Section 1.3 Indications For Use Page 13 of 24

Chison Medical Imaging Co., Ltd. 0 Series & i7. i8. iS Diagnostic Ultrasound Systems

System: QB/O8IO9/Q1O, i7/0i Diagnostic Ultrasound SystemsTransducer: VSC1OL, Volume Probe


Clinical Application Mode of 0teration

General Specific B Pw CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler Doppler Dopole Doppler Modes Imaging Other_


Intra-opcrative(Specify)Intra-operative (Neuro)ILaparoscopic

Small Organ"'SpecifyNeonatal Cephalic

Adult Cephalic

_____

Trans-rectalTrans-vaginal N N IN N N N N 3.4.5Trans-urethral

Trans-esoph. (non-Card.) ____

Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)Other (Urology) N N N N IN N N 510____ ther(Ob/GYN) N N N N N N N 5

Cardiac Cardiac AdultI_______ lCardiac PediatricJPen heral Vessel lPeriphSea vessel I____ I I I I I

N = new indication; P = previously cleared by FDA; E added under this appendixNote: 1. Combined modes are B3/M, 13+P WV, B/Color M, B/PWD or CWD, B/Color/PWD or CWD.B/Power/PWI)

2.SmaII Organ: Breast, testes, thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging orguidance or biopsy

Predicate transducer (K number): K 101 236


(Pant21 CFR 801 Subpart D) (21 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)





Chison Medical Imaging Co., Lid. 0 Series & I7, IS. i9 Diagnostic Ultrasound Systems

System: Q61Q8/Q9/O1O, i7Ii8fS D iagnostic Ultrasound SystemsTransducer: DSC2OL, Micra Convex Array


Clinical Application Mode of 0 nation

SGeneral Specific B M PW OW Color Power Combined Harmonic Other(Track I Only) (Tracks I & 3) B M Doppler Doppler Doppler Doppler Modes Imaging

Ophthalmic OphthalmicFetal Imaging & FetalOther Abdominal P P P P P p p 4.5

Intra-opcrative(Specify) __________

Intro-operative (Neumo) I I___

Laparoscoi IcPediatric P P P P P P P 4,5Small Organ'" I(Specify) __________

Neonatal Cephalic _________

Adult Cephalic ___ ____ _____

Trans-rectal ____________

Trans-vaginalTrans-urethralTrans-esoph. (non-

Card.) ____

Musculo-skeletal(Conventional)Musculo-skeletal(Superficial) _________ ________

Other (Urology) _________

___________Other (Ob/GYN) ________________

!Cardiac Crdiac AdultP_______ ardiac Pediatric P- P P ____ p p P P 5

lPeripheral Vessel lPeripheral vessel I___ I_____ ___I

N new indication; P =previously cleared by FDA; Ei added under this appendixNote: 1. Combined modes arc D/M, B+PWD. B/Color M. B/PWD orCWI). B/Color/PWD or CWD.B/Powcr/PWD

2.Snmall Organ: Breast. testes, thyroid3.3 DI4D Imaging Mode4.Elastography imaging5. Includes imaging or guidance of biopsy

Prescription Use X AND/OR Over-Thec-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFIR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)




section 1.3 indications For Use Page 15 of 24

Chison Medical Imaging Co.. Lid. Q Series & 0,.18, 9 Diagnostic Ulirasound Systems

System: Q61Q81Q9/Q1 0, i7/i81i9 Diagnostic Ultrasound SystemsTransducer: 05C20L-A, Micro Convex Array

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis ofthe human body as follows:

Cliiceal A ppl)icaltion ____ Modecor Iteration

General Specific11 P W CW Color I 'ooer Combined Ifarm, n ic Othe'r(Track I (ink) (Tracks I & 3) ____ ___ Doppler Doptr lDoppler Doppler Modes Iaingc

Ophthalmic Ophthalmic ___

Fetal Imaging & FetalOther Abdominal N N N ____ N N N N 4.5

Intra-operative(Specdly) ___ ______ ____

I nira-oiperati e (Neuro)LaparoscopicPediatric N N N ____ N N N N 4.5

Smal OrcnL'(Specily) ___ ________ _____

Neonatal CeplialicAdult Cephalic ___ ___ ____ _____

Trans-rectalirans-v'agi nal* Finns-u ret bra IIrans-esoph. (non-Card.) ___ ___ __________

Itiuset: -skeletalI Conventional)NI usculo-skeletal(Superficial) ______ _________

Other (Urology) ________ ____ __________

Other (Ob/GjYN) ______ _________

Cardiac Cardiac AdultCardiac Pediatric N N N _4 N N N N 5

Peripheral Vessel PleripEhrlvesselIIN = newv indication: 1P previously cleared by FDA: 1: = added under this appendix

Note : 1. (\ombi ned modes are HlI. 13+1' WI. li/Color NI. l3/'W I) or CWVD I). i/olor/I' WI or CW P. I3I'owecrll'WI)2.Sniall ( )gan: Brunast. testes. th.\roid3.31)/Il) lImaging Mode-l .Flastograph% imaging5inc ludes ijifleill or, 'uidanice of biopsy

Priedicate tranSducer (K numbecri: K 101236. K 12181

Prescription tise )< AND/OR Over-The-Counter Use ___

(Part 2 1 CFER 801 Subpaii D) (2 1 CER 807 Subpart C)(PLEASE DO0 NOT WRITE BELOWTIIS LINE-CONTINUE ON ANOI If-R PAGE If: Ni-I)ED)

Concurrence of CDRIl1, Office of Device Evaluation -(OD))

(IDivision Sign Ofi)Division of Radiological H ealth

Office of In Vitro IDiagnostic and Radiological I lcaith5 10k ____ _


Chison Medical Imaging Co., Lid. Q Series & Mi 18.19g Diagnostic Ultrasound Systems

System: QB/O8/09/Q 10, i7/iB/19 Diagnostic Ultrasound Systems

Transducer: 03C20L, Micro Convex Array


Clinical Application Mode of 0 eration ____

General Specific PW CW Color Power Combined Harmonic(Trak IOnl) (rack I 3) B MOther(Irak IOnl) (Iraks & ) B M DpperE Doper2pprDoper Modes Imaging

Ophthalmic Ophthalmic ____

Fetal Imaging & FetalOther Abdominal N N N _ _ N N N N 4,5

Inin-operative(Specify) _____________

Intre-operative (Neuro) ___ ____

LaparoscopicPediatricSmall Organ"1 (Specify) _________

Neonatal CephalicAdult Cephalic ____

Tran s-rect aTrans-vaginalTran s-u ret hralTrans-esoph. (non-

Card,) ________________

Musculo-skeletal(Conventional) ___________

Musculo-skeletal(Superficial)

Other (Uro ogy) N N N N N N N 5_________Other (ObtGYN) _ _ ___

ICardiac Cardiac Adult N IN N N N N N 5________Cardiac Pediatric N NI N N N N 5

Pecripheral Vessel Peripheral vesselN = new indication; P - previously cleared by FDA; E =added under this appendix

Note: 1. Combined modes are RIM. B+PWD, 8/Color M, BIPWD or CWD. BIColor/PWD or CWD.BPowecrPWD2.Small Organ: Breast, testes, thyroid3.3D1)4D Imaging Mode4.F.lastography imaging5. Includes imaging of' guidance of biopsy

Predicate transducer (K number): K 101236


(Part 21 CFR 801 Subpart D) (2)1 CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)




Section 1.3 indications For usre Page 17 of 24

Chison Medical Imaging Co.. Ltd. C Series & 17.,18. i9 Diagnostic Ultrasound Systems

System: 061081Q91Q10, i7/i8/19 Diagnostic Ultrasound SystemsTransducer: DOC 15L, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application ____ Mode of 0eration _________

General Specific PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks!I & 3) 11 M Doppler Doppler Doppjjr Doppler Modes Imaging Ote

Ophthalmic OphthalmicFetal Imaging & FetalOther Abdominal P P P P P P P 4.5

Intra-operative(specify)Intra-operative (Neuro) ____

LaparoscopicPediatric N N N N N N N 5

Neonatal Cephal icAdult Cephalic _____

Trans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-

Card.)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial) _____

Other (Urology)Other(Ob/GYN)

lCardiac ICardiac AdultI_______ ICardiac Pediatric ___ ____

jPeripheral Vessel P1eripheral vesselN - new indication; P = previously cleared by FDA: E =added under this appendixNote: :1 Combined modes arc BIM, B+PWD, B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Powcr/PWD

2.Small Organ: Breast, testes, thyroid3.3D14D Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy

Prescription Use )C AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 807 SubpartC)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)





Chison Medical Imaging Co., Ltd. C Series & 17. Il8. III Diagnostic Ultrasound Systems

System: O6/O8IQ9/O1O, 17118/iS Diagnostic Ultrasound Systems

Transducer: 0601 5L-A, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of thc human body as follows:Clinical Appication ____ Mode of 0peration ____________

General Specific B M PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) M DoppIc DopIcr Doppler Dapple Modes Imaging Ote


Fetal Imaging & FetalOther Abdominal N N N N N N N 4.5

Intra-operative(Specify) ____ ____

Intrit-operative (Neuro) I__I__II

Pediatric N N N N IN N N 5SmallI Organ'' (Specil) _________

eoasatal Cephalic _________ ________

dult Ccphalic ____ _____

rans-rectal _____ _____

ran s-u ret hralTrans-esoph. (non-

Card.) _ _ _ _

Musculo-skeletal(Conventional) ____

Musculo-skeletal(Superficial) ___ ____ ____

Other (Urology) _________

__________Other (Ob/GYN) _ ______

ardiac ICardiac Adult ____ _____

I________ ICardiac Pediatric ____ _____

leripheral Vessel IPeripheral vesselN - new indication; P = previously cleared by FDA; E =added under this appendix

Note: 1. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Powvcr/PWD2.Small Organ: Breast. testes, thyroid3.3D/4D imaging Mode4.Elastography imaging5. Includes imaging ofiguidance or biopsy

Predicate transducer (K number): K 101236. K 120801


(Part 21 CFR 801 Subpart D) (21 CER 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)




Section 1.3 Indications For Use Page 19 ot 24

Chison Medical Imaging Co.. Ltd. 0 Series & U, 18,.i9 Diagnostic Ultrasound Systems

System: Q6iQB/QS/Q1O, 17/i5/19 Diagnostic Ultrasound SystemsTransducer: D3P64L, Phased Array


Clinical Application Mode of 0peration _________

General Specific PW CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M Doppler Doppler2p r Doppler! Modes Imaging Ote


Intra-operalive(speify) ___ ___

Intra-operative (Neuro)LaparoscopicPediatricSmall Organ'(S-pecify) ___ ____ ____

Neonatal CephalicAdult Cephalic _____

Trans-rectalrrans-vaginalFrans-urethralrrans-esoph. (non-

Card.) __ ___ _ __

Miusculo-skelelal(Conventional) ______ _________

Musculo-skeletal(Superficial) _____

Other (Uology) ____

________Other (Ob/GYN) I_______

CricCardiac Adult P P P P p p Pp 5______________Cardiac PediatricPeriherl VeselPeripheral vessel

N =new indication; P = previously cleared by FDA; E - added under this appendixNote: 1. Combined modes arc RIM, B+PWD. B/Color M. 1/PWD or CWD. B/ColorIPWD or CWD.BlPower/PWD

2.Small Organ: Breast. testes, thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy

Prescription Use >( AND/OR Over-The-Counter Use ___





Secion 1.3 Indications For Use Page 20 of 24

Chison Medical Imaging Co., Ltd. C Series & 17.,19 i Diagnostic ultrasound Systems

System: 06106109/Q1O, W7/8/9 Diagnostic Ultrasound SystemsTransducer: DSP64L, Phased Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode ol peration _________

General specific l'W CW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) 13 M OtherDplr 2~r oper Mds mgn


I ntra-operative(Spec,&)latin-operative (Neuro)I

Lpocoic __________

PediatricSmall Organ" (SpeI~Neonatal Cephalic

Adult Cephalic _________

Trans-rectalTranis-vaginalTrans-urethrnalTrans-esoph. (non-Card.) _____

Musculo-skeletal(Conventi onalI) ___________

Musculo-skeletal(Superficial)Other (Urology) ___ ____

____________Other (Ob/GYN) ____

CardiacCardiac Adult

________ ardiac Peditric P P p P P P P p 5

N =new indication; P = previously cleared by FDA; Ei = added under this appendixNote: 1. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD, B/Color/PWD or CWD,I3/Powcr/PWD

2.Small Organ: Breast, testes. thyroid3.3D/4D Imaging Mode4.Elastography imaging5. Includes imaging orguidance of biopsy

Prescription Use )< AND/ORk Over-The-Counter Use ___






Chison Medical imaging Co.. Ltd. 0 Series & R.is. 19 Diagnostic Ultrasound Systems

System: O6IO8/091010, 17iMfi Diagnostic Ultrasound Systems

Transducer: D2D1B6L, Pencil Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0 eratlon _____ ________

General Specific PW CW Color Power Combined HarmonicOhr(Track I Only) (Tracks I & 3) B M Donnlij 221?n& Doppler Doppler Modes Imaging Ote

Ophthalmic OphthalmicFetallImaging & FetalOther Abdominal

Intra-operalive(Specify)Inlrat-operative (Neuro)LaparoscopicPediatricSmall Organ(peiy ____ ____

Neonatal Cephalic _____

Adult Cephalic ____

Tran s-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-

Card.) ____

Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)O0ther (Urology) _________

_________Oter (Ob/GYN) ______

ICardiac Criac Adutg N ____

___________Criac Pediatric N ____ _____

Perihera Vesel Priperal vesselN = new indication; P - previously cleared by FDA: EB = added under this appendixNote: 1. Combined modes arm B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Powcr/PWD

2.Sniall Organ: Breast. testes, thyroid3.30/41) Imaging Mode4.Elastography imaging5. Includes imaging of guidance or biopsy

Predicate transducer (K number): Kl101236


(Part 21 CFR 801 Subpart D) (21 CER 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH-, Office of Device Evaluation (ODE)


Office of In Vitro Diagnostic and Radiological Health5 10(k)

Section 1.3 Indicationts For Use Page 22 of 24

Chison Medical Imaeging Co.. Ltd. 0 Series & FT. i8. 19 Diagnostic Ultrasound Systems

System: Q6/08/Q9QO,7ri8119 Diagnostic Ultrasound SystemsTransducer: V4C4OL, Volume probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application Mode of 0 peratlon _________

General Specific B M PW OW Color Power Combined HarmonicOte(Track I Only) (Tracks I & 3) B M ~ Dopple Dapple~a Dopicr Modes Imaging Ote

Ophthalmic OphthalmicFetal Imaging & Fetal p p p p p p P 3.Other Abdominal P p p p p p p 3,41

Intra-operative(Specifyi) ___

Intra-operative (Neuro) ____

LaparoscopicPediatricSmall Organ'(Secfy ____

Neonatal CephalicAdult Cephatic _____

Trans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-

Card.)Musculo-skeletal(Conventional) _________

Musculo-skeletal(Superficial) _____

Other (Urology) P p p p p p p______Other (Ob/GYN) ____ P P P P____

Cardiac iCardiac Adult ____

I_____ _ IC ardiac Pediatric _________

jPeripheral Vessel jPeripheral vesse __________

N = new indication; P = previously cleared by FDA; E added under this appendixNote: 1. Combined modes are B/M. B+P Wi. 1/Color M. B/PWD or CWD. B/Color/P Wi or CWD,R/Power/PWD

2.Small Organ: Breast, testes, thyroid3.31)141 Imaging Mode4.Elastography imaging5. Includes imaging of guidance or biopsy







Chison Medical Imaging Co.. Ltd. Q Series & 17,1i8,19 Diagnostic Ultrasound Systems

System: Q6108/09/Q1O, 17/18/i9 Diagnostic Ultrasound SystemsTransducer: V4C4OL-C, Volume Probe


I- Clinical Application Mode of 0peration _________

General specific 13 M PW CW Color Power Combined Harmonic Other(Track I Only) (Tracks I & 3) B M oppe Dop Doppler Doppler Modes Imaging

Ophthalmic Ophthalmic ________ ___

Fetal Imaging & Fetal N N N N N N N 3.Other Abdominal N N N N IN N N 3.4

Intra-operative(specify') ___ ____ ___

Intra-operative (Neuro) I____I_

LaparoscopicPediatricSmallI Organ'(pc) __________

Neonatal CephalicAdult Cephalic _________

Tran s-rectal _____

Trans-vaginallTrans-urethralTrans-esoph. (non-

Card.l,___ __ ___ ___

usculo-skeletal(Conventional) _____

Musculo-skeletal(Superficial)Other (Urology) N N N N N N N

______Other (Ob/GYN) N N N N N N N!Cardiac iCardiac Adult 11 1 1

1________ ICardiac PediatricI I

lPeripheral Vessel P1eripheral vessel I I II IN = new indication; P - previously cleared by FDA; E =added under this appendixNote: 1. Combined modes arc B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Powvcr/PWD

2.SmaII Organ: Breast. testes. thyroid3.313/41D Imaging Mode4.Elastography imaging5. Includes imaging of guidance of biopsy

Predicate transducer (K number): K TO01236. K 12080)

Prescription Use >C AND/OR Over-The-Counter Use ___

(Part 2l CPR 80I Subpart D) (21 CFR 8O7SubpartC)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)



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