Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional ultrasound imaging modes and digital architecture, with no mention of AI or ML capabilities. The image processing mentioned (smoothing, edge enhancement) is standard digital signal processing, not indicative of AI/ML.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging or fluid flow analysis," not for therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging" and the "Device Description" explicitly mentions that it is "intended for clinical diagnostic imaging applications" and "is a general purpose, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and can be configured as a portable or roll-around model, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to produce images or analyze flow in vivo.
Device Description: The description details an "integrated preprogrammed color ultrasound imaging system" that "acquire ultrasound data and display the image." This further reinforces its function as an in vivo imaging device.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body (in vitro) to provide diagnostic information. The provided information does not mention any interaction with patient specimens or analysis performed outside the body.

Therefore, the SonoScape SSI-1000/SSI-5000 ultrasound system, as described, is a diagnostic imaging device used in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device 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.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Product codes

90 IYN, IYO, and ITX

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 architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000). These systems are designed with the latest technology, using the same quality procedures as ultrasound systems which have been available in the market for years.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes.

The major features of the SonoScape SSI-1000/SSI-5000:

64 Channel all digital beam former.
Progressive dynamic receive focusing.
Wide band all digital demodulation.
Native frequency digital scan converter.
SSI-1000 can be hand carried for portable use.
Remote access image management through LAN port.
USB2.0 flash drive for image transport and software upgrade.
Support for Phase array, Linear array, and Curve Linear array probes.
Based on Linux operating system.
Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.

The SSI-1000 utilizes an LCD viewing monitor, and the SSI-5000 uses a CRT monitor.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K970901, K991611, K010329

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

OCT 2 0 2004 PREMARKET NOTIFICATION [510(k)] Summary

| Trade Name: | SonoScape Ultrasound System, SSI-1000/SSI-5000TM
with PA2.5 MHz Phased Array, LA7.5 MHz Linear Array, and
CLA3.5 MHz Curved Linear Array. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO |
| Manufacturer's Name: | SonoScape Company Limited
4/F., Yizhe Building, Yuquan Road,
Nanshan, 518051, Shenzhen, China |
| Contact: | Mr. Jinzhong Yao, President
Telephone: (86) 755-26722890
Fax: (86) 755-26722850 |
| U.S. Agent: | Bob Leiker
Quality & Regulatory Services, Inc.
Dublin, CA 94568 |

GE Logiq 500 - K970901, K991611, and K010329 Predicate Device:

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 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

Image /page/0/Picture/7 description: The image shows a portable computer with a screen and keyboard. The computer is labeled "SSI-1000" at the bottom left of the image. The computer has a handle on top, suggesting it is designed to be carried around. The screen is dark, and the keyboard is visible below it.

for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

1

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

the latest technology, using the same quality procedures as ultrasound systems which have been available in the market for vears.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes.

The major features of the SonoScape SSI-1000/SSI-5000:

64 Channel all digital beam former .
Progressive dynamic receive focusing .
Wide band all digital demodulation .
Native frequency digital scan converter .
SSI-1000 can be hand carried for portable use .
Remote access image management through LAN port .
USB2.0 flash drive for image transport and software upgrade .
Support for Phase array, Linear array, and Curve Linear array probes .
Based on Linux operating system .
Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse . wave Doppler, and CW.

The SSI-1000 utilizes an LCD viewing monitor, and the SSI-5000 uses a CRT monitor. The following drawings are provided for illustration;

Image /page/1/Figure/17 description: The image shows three different models of medical equipment, labeled as SSI-1000 and SSI-5000. The SSI-1000 model is a boxy unit with horizontal ventilation slats. The SSI-5000 model has a monitor on top and an articulated arm extending from the side, and it is mounted on a wheeled base. The middle model has a monitor on top and is mounted on a wheeled base.

Premarket Notification 510(k) Summary

Image /page/1/Picture/21 description: The image shows a black and white picture of an SSI-5000 ultrasound machine. The machine has a monitor on top, a keyboard, and a control panel. The machine is on wheels, and there are cables hanging from the side. The image is a close-up of the machine, and the background is blurred.

2

Intended Use: The device 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.

Technological Characteristics

| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and
Triplex 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 Vascular
package |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric material in the transducer and
detect the reflected echo to construct the 2-D B-mode, Doppler color, and Doppler
spectrum image for diagnostic purpose. |
| Operating
Controls | 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 Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
| Acoustic
Output | Track 3; MI, TIS, TIC, TIB
Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical
Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max |
| Safety
Compliance | IEC601-1 International Electrotechnical Comission; Medical Electrical Equipment
IEC60601-2 International Electrotechnical Comission; Electromagnetic
Compatibility |

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

SonoScape Company, Ltd. % Mr. Bob Leiker Quality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568-2330

Re: K042369

י

;

Trade Name: SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System 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: 90 IYN, IYO, and ITX Dated: October 11, 2004 Received: October 12, 2004

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 SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1, PA2.5 MHz Phased Array L741, LA7.5 MHz Linear Array C344, CLA3.5 MHz Curved Linear Array

4

Page 2 - Mr. Leiker - - - -

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), W 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and . prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address {"http://www.fda.gov/cdrh/dsmamain.html".

5

Page 3 - Mr. Leiker

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

:

· Sincerely yours,

Nancy C Brogdon

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

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6

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 Oneration

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		N	N	N		N	N		Note 1	N
Ob/GYN		N	N	N		N	N		Note 1	N
IntraOperative
Neurological
Pediatric
Small Organ (breast,
thyroid, testes)		N	N	N		N	N		Note 1	N
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		N	N	N		N	N		Note 1	N
Laparascopic
Muscular-Skeletal
Conventional		N	N	N		N	N		Note 1	N
Muscular-Skeletal
Superficial
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:

Concurrence of CDRH, Office of Device

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
Page 2 of 5 Uno

Prescription Use (Per 21 CFR 801.109)

Indications For Use 510(k) Number ____________________________________________________________________________________________________________________________________________

7

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:

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
Ob/GYN
IntraOperative
Neurological
Pediatric
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-Skeletal
Conventional
Muscular-Skeletal
Superficial
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:

Concurrence of CDRH, Office of D

Nancy C. Bergdon

(Division S Division of Reproductive and Radiological Device 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Indications For Use

8

.

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined | Tissue
Harmonic
Imaging |
|------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|----------|-------------------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Ob/GYN | | | | | | | | | | |
| IntraOperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,
thyroid, testes) | N | 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 | N | | Note 1 | N |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | N | N | N | | N | N | N | | Note 1 | N |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| 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:

Concurrence of CDRH, Office of Device Evaluation (ODE

Nancy C. hogdon
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, and Radiological Dovices

Indications For Use I - Indications For Use

9

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 Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined	Tissue
Harmonic
Imaging
Opthalmic
Fetal
Abdominal		N	N	N		N	N	Note 1	N
Ob/GYN		N	N	N		N	N	Note 1	N
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-Skeletal
Conventional
Muscular-Skeletal
Superficial
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:

Concurrence of CDRH, Office of Device Evaluation (OD

Nancy C brondon

(Division Sign-Off Division of Reproductive, Abdo and Radiological Devices 510/k) Number _________

Prescription Use (Per 21 CFR 801.109)