The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen: Pediatric: Small Organ (breast, tests, thyroid): Heart Soft Tissue; Peripheral Vascular; Musculo-skeletal (conventional) and Urology.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Device Description

The CHISON Q3/Q5/Q6/Q8/iVis60/iVis60 EXPERT ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q3/Q5/Q6/Q8), or as a roll-around model on wheels (iVis60 / jVis60 EXPERT). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, 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, or a combination of these modes.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the CHISON Q8/Q6/Q5/Q3 Roll (Portable) and iVis 60 & iVis 60 EXPERT (Rollaround) Diagnostic Ultrasound Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information:

A table of acceptance criteria and reported device performance.
Details on sample size used for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
Any information about a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human readers with/without AI assistance.
Data from a standalone (algorithm only) performance study.
Information on the type of ground truth used (pathology, outcomes data, etc.).
Sample size for the training set or how ground truth for the training set was established.

Summary of Device Equivalence Instead of Performance Acceptance Criteria:

The key to this 510(k) submission is demonstrating substantial equivalence to a predicate device, the SonoScape SSI-1000 ultrasound system (K052042). This means the manufacturer is asserting their device is as safe and effective as the predicate device, not necessarily that it meets predefined quantitative performance metrics.

The study that "proves" the device meets the acceptance criteria is actually the comparison to the predicate device as outlined in Section 5 of the 510(k) Summary.

Details from the submission regarding this "proof":

Device Comparison: "The CHISON Q Models and iVis60 Models are of comparable type and substantially equivalent to the current SSI-1000/SSI-5000 (K052042)."
Operating Principles: "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device."
Capabilities: "All systems allow for specialized measurements of structures and flow, and calculations. The systems have the same gray-scale and Doppler capabilities."
Safety Standards: The CHISON ultrasound system meets safety standards: NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.
Acoustic Output: "The systems have acoustic output levels below the applicable FDA limits."
Intended Use Compatibility: The device shares similar indications for use across various clinical applications (Abdomen, Pediatric, Small Organ, Heart, Soft Tissue, Peripheral Vascular, Musculo-skeletal (conventional), and Urology) and operating modes (B-Mode, M-Mode, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Directional Power Doppler) with the predicate device, as detailed in the "Indications For Use" section for the system and each transducer.

In essence, for a 510(k) submission like this, the "acceptance criteria" are the demonstration of comparable intended use, technology, fundamental operating principles, and safety/effectiveness as a legally marketed predicate device. The "study" proving this is the comparative analysis presented in the 510(k) summary itself, rather than a clinical trial with specific performance endpoints.

Summary

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K091877

SEP - 2 2009

PREMARKET NOTIFICATION [510(k)] Summary

This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).

1. Company Name:
  Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142 Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142
Contact: Ms. Ruoli Mo Tel: +86-510-85311707, 85310593 Fax: +86-510-85310726
U.S. Agent: Bob Leiker Leiker Requlatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568 Telephone: 925-556-1302
1. Device Name: CHISON Q8/Q6/Q5/Q3 Roll (Portable) Diagnostic Ultrasound System CHISON iVis 60 & iVis 60 EXPERT (Rollaround) Diagnostic Ultrasound System
  Common/Usual Name: Diagnostic Ultrasound System with Accessories

Classification: Requlatory Class: II Review Category: Tier II

Classification Name	21 CFR Section	Product Code
Ultrasonic pulsed doppler imaging system	892.1550	90-IYN
Ultrasonic pulsed echo imaging system	892.1560	90-IYO
Diagnostic ultrasonic transducer	892.1570	90-ITX

2. Marketed Device:

K052042, SonoScape SSI-1000 ultrasound system

3. Device Description:

The CHISON ultrasound system can be configured either as a portable model (Q3/Q5/Q6/Q8), or as a roll-around model on wheels (iVis60 / jVis60 EXPERT). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years.

...

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This CHISON ultrasound system is a general purpose, software controlled, 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, or a combination of these modes.

The CHISON Q Models and iVis60 Models, have been designed to meet the following product safety standards: NEMA UD 3, IEC 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.

4. Indications for Use:

5. Comparison to Predicate Device:

The CHISON Q Models and iVis60 Models are of comparable type and substantially equivalent to the current SSI-1000/SSI-5000 (K052042). All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow. and calculations.

6. Conclusion:

The CHISON Q Models and Vis60 systems are substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale and Doppler capabilities. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.

End of 510(k) Summary.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP - 2 2009

Chison Medical Imaging Co., Ltd. % Mr. Bob Leiker Owner and Manager Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568

Re: K091877

Trade/Device Name: CHISON iVis 60 & Q Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 17, 2009 Received: June 23, 2009

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the CHISON iVis 60 & Q Series Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

D3P64L, 2-4.4MHz Phased Array D3C60L, 2-5.8MHz Convex Array D5C20L, 3-8.5MHz Pediatric Micro-convex Array D6C12L, 4-9.9MHz Transvaginal/Transrectal Micro-convex Array D7L40L, 4-13MHz Linear Array

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Page 2 - Mr. Job

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to procced to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Mr. Paul J. Hardy at (301) 796-6542.

Sincerely yours.

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications For Use

System:

CHISON iVis 60 & Q Series Diagnostic Ultrasound Systems Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWDNote 3	ColorDoppler	Power(Amplitude)Doppler	Other*Combined
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	Note 1
	Small Organ[1] (Specify)	N	N	N		N	N	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1
	Trans-vaginal	N	N	N		N	N	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	N	Note 1
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1
	Cardiac Pediatric	N	N	N	N	N	N	Note 1
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	Note 1
	Other (Specify)

P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [ ] Small Organ: breast, thyroid, testes Note 3: CWD Mode is not available on all transducers. Additional Comments:

Prescription Use √

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System:

CHISON iVis 60 & Q Series Ultrasound Systems D3P64L, 2-4.4MHz Phased Array Transducer:

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

Clinical Application			Mode of Operation

General	Specific	B	M	PWD	CWD	Color	Power	Other*
(Track 1 Only)	(Tracks 1 & 3)				Note 3	Doppler	(Amplitude)	Combined
							Doppler
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro).
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	z	N	N	Note 1
	Cardiac Pediatric	N	N	N	ನ	N	N	Note 1
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel Peripheral vessel
	Other (Specify)
1 - - - - -- -	indiantian -D ============================================================================================================================================================================

P = previously cleared by FDA; N = new indication; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: breast, thyroid, testes Note 3: CWD Mode is not available on all transducers. Additional Comments:

Prescription Use ✓
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __
(21 CFR 801 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 Reproductive, Abdominal,
and Radiological Devices
Section 1.3

Labels	Values
510(k) Number	K091877

Indications For Use
Page 3 of 7

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System: CHISON iVis 60 & Q Series Ultrasound Systems Transducer: D3C60L, 2-5.8MHz Convex Array

Clinical Application		Mode of Operation
		B	M	PWD	CWDNote 3	ColorDoppler	Power(Amplitude)Doppler	Other*Combined
General(Track 1 Only)	Specific(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	FetalAbdominal	N	N	N		N	N	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel
	Other (Specify)

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K091877
Indications For Use
Page 4 of 7

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System: CHISON iVis 60 & Q Series Ultrasound Systems Transducer: D5C20L, 3-8.5MHz Pediatric Micro-convex Array

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWDNote 3	ColorDoppler	Power(Amplitude)Doppler	Other*Combine
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N	N	N	N	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	Note 1
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1
	Cardiac Pediatric	N	N	N	N	N	N	Note 1
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel
	Other (Specify)

Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: breast, thyroid, testes Note 3: CWD Mode is not available on all transducers.

Additional Comments:

Prescription Use	✓	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 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 Reproductive, Abdominal, ogical Device and Radio 510(k) Number

Indications For Use

{8}------------------------------------------------

System: CHISON iVis 60 & Q Series Ultrasound Systems Transducer: D6C12L, 4-9 9MHz Transvaginal/Transrectal Micro-convex Array

Clinical Application		Mode of Operation

General	Specific	B	M	PWD	CWD	Color	Power	Other*
(Track 1 Only)	(Tracks 1 & 3)				Note 3	Doppler	(Amplitude)Doppler	Combined
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small OrganII (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1
	Trans-vaginal	N	N	N		N	N	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel
	Other (Specify)

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

P = previously cleared by FDA, N = new indication; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: breast, thyroid, testes Note 3: CWD Mode is not available on all transducers.

Additional Comments:

Prescription Use(Part 21 CFR 801 Subpart D)	✓
AND/OR	Over-The-Counter Use(21 CFR 801 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 Reproductive, Abdominal, and Radiological Devices

510(k) Number	K091877
---------------	---------

Indications For Use

Page 6 of 7

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CHISON iVis 60 & Q Series Ultrasound Systems System: Transducer: D7L40L, 4-13MHz Linear Array

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWDNote 3	ColorDoppler	Power(Amplitude)Doppler	Other*Combined
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)	N	N	N		N	N	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	N	Note 1
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	Note 1
	Other (Specify)

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: breast, thyroid, testes Note 3: CWD Mode is not available on all transducers. Additional Comments:

Prescription Use √
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __
(21 CFR 801 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 Reproductive, Abdominal, and Radiological Devices 510(k) Nection 1 3

Indications For Use

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.