The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for S8 Diagnostic Ultrasound System.
| Device ID | K112451 |
| 510k Number | K112451 |
| Device Name: | S8 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SONOSCAPE COMPANY LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2011-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868698010 | K112451 | 000 |
| 06945868600259 | K112451 | 000 |
| 06945868600266 | K112451 | 000 |
| 06945868600273 | K112451 | 000 |
| 06945868600280 | K112451 | 000 |
| 06945868600297 | K112451 | 000 |
| 06945868600310 | K112451 | 000 |
| 06945868600334 | K112451 | 000 |
| 06945868600389 | K112451 | 000 |
| 06945868600396 | K112451 | 000 |
| 06945868600426 | K112451 | 000 |
| 06945868600440 | K112451 | 000 |
| 06945868698003 | K112451 | 000 |
| 06945868600211 | K112451 | 000 |