The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Sonoscape Ultrasound System Ssi-1000/ssi-5000.
| Device ID | K042369 |
| 510k Number | K042369 |
| Device Name: | SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SONOSCAPE COMPANY LIMITED 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-20 |
| Summary: | summary |