SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K041455 · Sonoscape Company Limited · IYO · Jun 10, 2004 · Radiology

Device Facts

• Record ID: K041455
• Device Name: SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
• Applicant: Sonoscape Company Limited
• Product Code: IYO · Radiology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.

Device Story

Portable electronic convex/linear scanning ultrasonotomograph; utilizes ultrasonic pulsed echo technology to generate tomographic images. Input: ultrasonic signals from C343 convex or L751 linear transducers. Processing: digital scan converter (DSC) and CPU module transform signals into B, B/B, B/M, or M-mode images. Output: video monitor display of anatomical structures; includes measurement functions (distance, area, volume, HR, etc.). Used in clinical settings by healthcare professionals for diagnostic imaging. Clinicians view images on 10/12-inch monitors to assess fetal, abdominal, cardiac, and small organ health; aids in clinical decision-making through visualization and quantitative measurements.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electronic convex/linear scanning; B, B/B, B/M, M display modes; 256 grey scale; 2.5-10MHz probe frequency; variable aperture 1-4 focal zone electronic focusing; 512x512x8 bit DSC memory; RS-232C connectivity; PAL/NTSC video output; 100VA power consumption; operating temperature 5-40°C.

Indications for Use

Indicated for fetal, abdominal, pediatric, cardiac, small organ (thyroid, parotid, submaxillary gland, testes, breast), and peripheral vascular imaging. For use by clinicians in clinical settings.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Medison SonoAce 600 (K000030)

Submission Summary (Full Text)

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204455

### 'JUN 1 0 2004

# Premarket Notification [510(k)] Summary

| Trade Name: | SSI-600 / SSI-800 with C343 and L751 Transducers |
|-------------------------|--------------------------------------------------------------------------------|
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO<br>(per 21 CFR section 892.1560) |
| Manufacturer's Name: | SonoScape Company Limited |
| Address: | 4/F., Yizhe Building, Yuquan Road,<br>Nanshan, 518051, Shenzhen, China |
| Corresponding Official: | Mr. Jinzhong Yao |
| Title: | President |
| Telephone: | (86) 755-26722890 |
| Fax: | (86) 755-26722850 |

Medison SonoAce 600 K000030 Predicate:

Model SSI-600/SSI-800 are linear and convex electronic Device Description: scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit of SSI-600 is portable and separable from other equipment to be carried for its use at another place as well as being usable in combination with a 10-inch video monitor and a special photographic unit. The main unit of SSI-800 is able to combine with a 12-inch video monitor and a special photographic unit.

Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.

#### Technological Characteristics:

(1) Scanning method: Electronic convex sector scanning, linear scanning

- (2) Display mode: B, B/B, B/M, M
- (3) Grey scale: 256

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- (4) Frequency of probes: 2.5MHz to 10MHz
- (4) Frequency of probot: E.S.R.H.S. X1.2, X1.5, X2.0, Shift 2mm step
(5) Image Display multiple: X0.8, X1.0, X1.2, X1.5, X2.0, Shift 2mm step
- (5) Image Display malliplo: Xero, 1111)
(6) Focusing method: Variable aperture 1-4 focal zone electronic focusing
- (7) Display range (max)

Depth 200mm angel 80° (Convex)

Depth 90mm width 50mm (Linear)

#### (8) Image adjustment

0 to 99 (digital) Gain: 0 to -60 (digital) Near Gain: 0 to 60 (digital) Far Gain: Grey map curve: 4 types Frame Correlation: 4 steps Edge Enhance: 4 steps

(9) Sweep Speed in M Mode: 1, 2, 4, 8sec/frame

- Image Display: left/right, positive/negative (10)
- Cineloop: up to 64 frames, continual/single (11)
- DSC memory capacity: 512 X 512 X 8 bit (12)
- Monitor: 10-inch B/W monitor (13)
- Character display (14)
- (a) Patient's ID
- (b) Hospital Name
- (c) Comment
- (d) Automatically Display Items: Date & time, probe frequency, gain and other operating parameters, and various measured values.
- Body marks: 25 types (15)
- Measuring functions: (16)
- (a) Basic measurement: distance, circumference, area, volume, angle, HR
- (b) Obstetrics measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG
- (c) Other measurements: MV,LV,TIME,SLOPE,AO
- I/O port (17)
- (a) RS-232C port for transmitting image to PC
- (b) One active convex or linear array ports
- Video system: 625lines/frame, 50fields/second (PAL) (18) or 525lines/frame, 60fields/second (NTSC)
- Dimension 310(W) x 383(L) x 263(H) mm (19)
- Net Weight: about 12kg (20)
- Power Consumption: ~~220V±10%, 100VA (21)

Or ~110V±10%, 100VA

- Environmental Requirements: (22)
- (a) Operating Temperature & Humidity: 5°C to 40°C, 30% to 85%RH
- (b) Atmospheric Pressure: 70 to 160 KPa (700 to 1600 mbars)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

Public Health Service

JUN 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SonoScape Company Limited % Mr. Bob Leiker Quality and Regulatory Services, Inc. 7263 Cronin Circle DUBLIN CA 94568

Re: K041455

Trade Name: SSI-600 / SSI-800 Diagnostic Ultrasound Systems 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 IYO and ITX Dated: May 24, 2004 Received: June 1, 2004

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your beenon o succernined 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 interstate confinered provices that have been reclassified in accordance with the provisions of the Amendinents, of to devices market Act (Act). You may, therefore, market the device, subject to I edital I ood, Drag, and Oosment Free Act. The general controls provisions of the Act include the general controls provisions of on, 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 1 Ins uctimmation of backandar iagnostic Ultrasound Systems, as described in your premarket notification:

#### Transducer Model Number

#### C343 Convex Array L751 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

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can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oouoverements concerning your device in the Federal Register. may publish finitier announce of a substantial equivalence determination does not mean r least be advised that I Driving that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacharter und regulanents . including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607); adoling (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 This letter will anow you to organization equivalence of your device to a legally marketed nontication. 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 11 you debre of Compliance at [phone]. Additionally, for questions on the comact the Office of compilance at (vice, please contact the Office of Compliance at (301) 594promotion and acreralisms or your tion entitled, "Misbranding by reference to premarket 4057. Also, produse note the regarial information on your responsibilities under the nothreation (21 St. 21 to an the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

David A. Segerson
Nancy C. Broadgon

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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# 3.1 SonoScape SSI-600/SSI-800 Ultrasound Imaging System

### Scanhead Indications for Use Form Device Name: Convex Array C343

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethrat | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Perpheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication

N Hew indivation
Additional Comments: Pediatric Comments: Pediatric Intended uses include: Cardiology, Abdomen

Indicatio

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED.

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Heymann

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SonoScapeCompany,LTD.

1

# SonoScapeCompany,LTD.
3.2 SONOSCAPE SSI-600/SSI-800 Ultrasound Imaging System

# Scanhead Indications for Use Form

Device Name: Linear Array L751

| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | | | | | | | | | |
| Small Organ (specify) | | N | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethrat | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication

N=Hicw includion
Additional Comments: __Small organs includes: thyroid_parotid_submaxillary_gland_testes_and breast_

Pediatric Intended uses include: Peripheral Vasa Pediatric Comments:

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

Concurrence of CDRH, office of Device Evaluation (ODE)

David Ch. Lyron

(Division Sign-Off) oductive Ab Division of and Radiological D Indication5fbf0(is): Number

Prescription Use (Per 21 CFR 801.109)

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SonoScapeCompany,LTD.

510(K) Submission

# SonsscapeCompany,LTD.
3.3 SONOSCAPE SSI-600/SS1800 Ultrasound Imaging System

#### Indications for Use Form

### Diagnostic Ultrasound System Indications for Use Form

Device Name: SSI-600/SSI-800

| Clinical Application | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | | |
| Abdominal | | N | N | | | | | | N | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | | |
| Small Organ (specify) | | N | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethrat | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Perpheral Vascular | | N | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication

Prescription Use (Per 21 CFR 801.109)

14 YOW Travents: _____________________________________________________________________________________________________________________________________________________________ Pediatric Comments: Pediatric Intended uses include: Peripheral Vasa

please do not write below this line - continue on another page if needed in

Concurrence of CDRH, office of Devige Evaluation (ODE)

David Ch. Lyram

(Division Division and Rad

Indications \$1 (JKK) P