SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

{0}------------------------------------------------ 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 {1}------------------------------------------------ - (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) {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 (301) 594-4591. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212. 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) {4}------------------------------------------------ # 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 {5}------------------------------------------------ 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) {6}------------------------------------------------ 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