Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal; Pediatric; Small Organ (breast, thyroid, testes); Peripheral Vascular; Musculo-skeletal (conventional) and Urology.

Device Description

The SonoScape SSI-1000/SSI-5000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations.

The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000).

AI/ML Overview

This is an FDA 510(k) Premarket Notification document, which primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria. Therefore, the information requested about a device performance study, acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document.

The document lists the intended uses for various transducers of the SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System. These tables show what the device is intended to do (e.g., "Abdominal", "Cardiac", "Small Organ" imaging) and which modes of operation it supports for each application (e.g., B-mode, M-mode, Pulsed Wave Doppler, Color Doppler). The 'P' indicates 'previously cleared by FDA', 'N' indicates 'new indication', and 'E' indicates 'added under Appendix E'.

While this document confirms the intended uses, it does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity) for these uses against defined acceptance criteria, nor does it describe a study to demonstrate such performance characteristics. The basis for clearance is substantial equivalence to predicate devices, implying that the new device performs at least as well as the older cleared devices, but without detailing specific comparative performance data in this summary.

Therefore, I cannot provide the requested information regarding acceptance criteria and the performance study, as it is not contained within the provided text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2005

SonoScape, Inc. % Mr. Bob Leiker Ouality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568

Re: K052042

Trade Name: SonoScape SSI-1000/SSI-5000TM

Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560

Regulation Name: Ultrasonic pulsed echo imaging system . Regulation Number: 21 CFR 892.1570

Regulation Name: Diagnostic ultrasonic transducer . Regulatory Class: II

Product Code: IYN, IYO, and ITX

Dated: July 25, 2005

Received: July 28, 2005

Dear Mr. Leiker:

This letter corrects our substantially equivalent letter of August 9, 2005 regarding a wrong transducer number.

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 SonoScape SSI-1000/SSI-5000™, as described in your premarket notification:

Transducer Model Number

2P1, PA2.5 MHz Phased Array L741, LA7.5 MHz Linear Array

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C344. CLA3.5 MHz Curved Linear Array MPTEE, 7-4 MHz/10mm/64 element Multi-Plane Transesophageal Phased Array 5P1. 7-4 MHz/10mm/64 element Phased Array C611. 8-4 MHz/R11mm/128 element Micro-convex Array 6V1, 8-4 MHz/R11mm/128 element Transvaginal Micro-convex Array 10L1, 12-5 MHz/38mm/128 element Flat Linear Array

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 proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Leggett

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number: __

Device Name: SonoScape SSI-1000/SSI-5000 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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Color Velocity Imaging	Combined Tissue Harmonic Imaging
Opthalmic
Fetal
Abdominal		P	P	P		P	P		Note 1 N
Ob/GYN		P	P	P		P	P		Note 1 N
IntraOperativeNeurological
Pediatric		N	N	N	N	N	N		Note 1 N
Small Organ (breast, thyroid, testes)		P	P	P		P	P		Note 1 N
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		Note 1 N
Transesophageal		N	N	N	N	N	N		Note 1 N
Trans-Rectal		N	N	N		N	N		Note 1 N
Trans-Vaginal		N	N	N		N	N		Note 1 N
Trans-Urethral
Intra-Vascular
Peripheral Vascular		P	P	P		P	P		Note 1 N
Laparascopic
Muscular-SkeletalConventional		P	P	P		P	P		Note 1 N
Muscular-SkeletalSuperficial
Others (Specify)

P = previously cleared by FDA E = added under Appendix E N = new indication

Coabined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and Note 1: B/Power Doppler/PWD

Additional Comments:

Commissioner of CDRH, Office of Device Evaluation (ODE)

Nancy Chrogdon

Prescription Use (Per 21 CFR 801.109)

(Division Division ve, Abdominal, Indications F ge 2 of 10

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510(k) Number: __

Device Name: 2P1, PA2.5 MHz Phased Array Diagnostic Ultrasound Transducer

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

Clinical Application	Mode of Operation								TissueHarmonicImaging
	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging		Combined
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperative
Neurological
Pediatric
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		Note 1	P
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

P = previously cleared by FDA N = new indication E = added under Appendix E

Note 1: Combined includes: BM; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

CDRH. Office of Device Evaluation (OD)

Nancy Brogdon

(Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Reproductive and Radiological Devices 5 1 Officialistians For Use

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510(k) Number: _

Device Name: L741, LA7.5 MHz Linear Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic uitrasound imaging or fluid flow analysis of the human body as follows: Mode of Oneration

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperative
Neurological
Pediatric
Small Organ (breast,thyroid, testes)	P	P	P			P	P		Note 1	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular	P	P	P			P	P		Note 1	P
Laparascopic
Muscular-SkeletalConventional	P	P	P			P	P		Note 1	P
Muscular-SkeletalSuperficial
Others (Specify)

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

ence of CDRH, Office of Device Evaluation (ODE)

Nancyebro

(Division Sign O

and Radiological 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Section 4.3

Indications For Use

Page 4 of 10

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: C344, CLA3.5 MHz Curved Linear Array Diagnostic Ultrasound Transducer

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal	P	P	P	P		P	P		Note 1	P
Ob/GYN	P	P	P	P		P	P		Note 1	P
IntraOperative
Neurological
Pediatric
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

N = new indication P = previously cleared by FDA E = added under Appendix E

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

or of CDRA Ortion of Deveror & valuation (ODE)

Nancy C. Brogdon
Division Sign-Off)

(Division Sign Division of Reproduc and Partino at Indications For Use it Her

Prescription Use (Per 21 CFR 801.109) Section 4.3

age 5 of 10

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: MPTEE, 7-4MHz/10mm/64 element Multi-Plane Transesophageal Phased Array Diagnostic Ultrasound Transducer

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	N	N	N	N	N	N	N		Note 1	N
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

N = new indication P = previously cleared by FDA E = added under Appendix E

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
510(k) Number K052042
Prescription Use (Per 21 CFR 801.109)

Section 4.3

Indications For Use

Page 6 of 10

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: 5P1, 7-4MHz/10mm/64 element Phased Array Diagnostic Ultrasound Transducer

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperativeNeurological
Pediatric		N	N	N	N	N	N		Note 1	N
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		Note 1	N
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

N = new indication P = previously cleared by FDA E = added under Appendix E

Note 1: Combined includes: BM; BPWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc Broglon
(Division Sign Off)

Division of Repro clive. Altominal, and Radiological Device Indications of on thember Page 7 of 10

Prescription Use (Per 21 CFR 801.109)

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510(k) Number: __

Device Name: C611, 8-4MHz/R11mm/128 element Micro-convex Array Diagnostic Ultrasound Transducer

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperativeNeurological
Pediatric		N	N	N		N	N		Note 1	N
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		Note 1	N
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

P = previously cleared by FDA N = new indication E = added under Appendix E

Note I: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc bogdon
(Division Sign-Off)

Division of Repro Abd minal and Radiological De Indications FREFFAFA imber of 10

Prescription Use (Per 21 CFR 801.109)

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510(k) Number: _

Device Name: 6V1, 8-4MHz/R11mm/128 element Transvaginal Micro-convex Array Diagnostic Ultrasound Transducer

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN		N	N	N		N	N		Note 1	N
IntraOperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal		N	N	N		N	N		Note 1	N
Trans-Vaginal		N	N	N		N	N		Note 1	N
Trans-Urethral
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-SkeletalConventional
Muscular-SkeletalSuperficial
Others (Specify)

N = new indication P = previously cleared by FDA E = added under Appendix E

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, and Radiological Devic Indications: Egytis finder Page 9 of 10

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510(k) Number: K052042

Device Name: 10L1, 12-5MHz/38mm/128 element Flat Linear Array Diagnostic Ultrasound Transducer

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

Clinical Application	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	Combined	TissueHarmonicImaging
Opthalmic
Fetal
Abdominal
Ob/GYN
IntraOperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)	N	N	N	N	N	Note 1	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular	N	N	N	N	N	Note 1	N
Laparascopic
Muscular-SkeletalConventional	N	N	N	N	N	Note 1	N
Muscular-SkeletalSuperficial
Others (Specify)

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

f CPRER, Office of Devic
currence of CDRH, Office of Device Evaluation (ODE)

Indications For Use

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Prescription Use (Per 21 CFR 801.109)

ised Page 10 of 10

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AUG 9 - 2005

PREMARKET NOTIFICATION [510(k)] Sum

SonoScape Ultrasound System, SSI-1000/SSI-5000™ with 6V1 Trade Name: Micro-convex EndoCavity Linear Array, 10L1 Linear Array, MPTEE Multi-plane Trans-Esophageal Phased Array, 5P1 Phased Array, and C611 Micro-Convex Linear Array transducers.
Diagnostic Ultrasound System and Transducers Common Name:
Classification Names: Ultrasonic Pulsed Echo Imaging System, 90 IYO Ultrasonic Pulsed Doppler Imaging System, 90 IYN Diagnostic Ultrasound Transducer, 90 ITX

Manufacturer's Name: SonoScape Company Limited

4/F. Yizhe Building, Yuquan Road,

Nanshan, 518051, Shenzhen, China

Mr. Jinzhong Yao, President Contact:
Telephone: (86) 755-26722890

Fax: (86) 755-26722850

Bob Leiker U.S. Agent: Quality & Regulatory Services, Inc. Dublin, CA 94568
SonoScape SSI-1000/SSI-5000, K042369 and the GE LogiQ 500, Predicate Devices: K970901, K991611, and K010329

The SonoScape SSI-1000/SSI-5000 ultrasound system is an Device Description: integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000).

Attachment O

Premarket Notification 510(k) Summary

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Intended Use: The device is a general-purpose ultrasonic imaging instrument intended for The device is a general purpose raluation of Abdomen; Pediatric; Small Organ ( use by a qualifica physician rooft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

Technological Characteristics

Display Modes	Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler andTriplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time
Measurements	Distance; area; circumference; calipers; velocity, PI, RI. Cardiac. OB and Vascularpackage
Principle ofOperation	Applying high voltage burst to the Piezoelectric material in the transducer anddetect the reflected echo to construct the 2-D B-mode, Doppler color, and Dopplerspectrum image for diagnostic purpose.
OperatingControls	TGC 8 slider, +/- 24dB Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 5 curves over 50-90 dB Gray Scale Control: 8 Settings Focal Number: 16 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve over 15-48 dB Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and position Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: 1 to 10 continuously Cine control: step, play backward, play continuously
AcousticOutput	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, MechanicalIndex: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max
DisplayAnnotations	Time/date/year; transducer type; power output in %; frames per second;persistence; and compression settings; image depth; patient name and ID;institution name; focal position; TGC curve display; Doppler & M scale in sec;Doppler angle correction cursor; EKG trace; probe tip temperature / angle forMPTEE; free form annotation anywhere on image; trackball controlled; selective onglobal erase of the display annotations, body markers with transducer annotations
SafetyCompliance	IEC601-1 International Electrotechnical Commission; Medical Electrical EquipmentIEC60601-2 International Electrotechnical Commission; ElectromagneticCompatibility

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.