The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Sii Ultrasound System.
| Device ID | K160734 |
| 510k Number | K160734 |
| Device Name: | SonoSite SII Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Patricia Liau |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2016-03-17 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105549 | K160734 | 000 |
| 00841517101398 | K160734 | 000 |
| 00841517101411 | K160734 | 000 |
| 00841517101824 | K160734 | 000 |
| 00841517101985 | K160734 | 000 |
| 00841517102012 | K160734 | 000 |
| 00841517102081 | K160734 | 000 |
| 00841517102159 | K160734 | 000 |
| 00841517102401 | K160734 | 000 |
| 00841517101251 | K160734 | 000 |
| 00841517100216 | K160734 | 000 |
| 00841517106836 | K160734 | 000 |
| 00841517107567 | K160734 | 000 |
| 00841517106744 | K160734 | 000 |
| 00841517106751 | K160734 | 000 |
| 00841517106621 | K160734 | 000 |
| 00841517106669 | K160734 | 000 |
| 00841517106454 | K160734 | 000 |
| 00841517100124 | K160734 | 000 |
| 00841517102425 | K160734 | 000 |
| 00841517102449 | K160734 | 000 |
| 00841517103774 | K160734 | 000 |
| 00841517104474 | K160734 | 000 |
| 00841517104481 | K160734 | 000 |
| 00841517104573 | K160734 | 000 |
| 00841517104702 | K160734 | 000 |
| 00841517105303 | K160734 | 000 |
| 00841517105525 | K160734 | 000 |
| 00841517105532 | K160734 | 000 |
| 00841517103767 | K160734 | 000 |
| 00841517103682 | K160734 | 000 |
| 00841517102456 | K160734 | 000 |
| 00841517102463 | K160734 | 000 |
| 00841517102470 | K160734 | 000 |
| 00841517103569 | K160734 | 000 |
| 00841517103583 | K160734 | 000 |
| 00841517103606 | K160734 | 000 |
| 00841517103613 | K160734 | 000 |
| 00841517103675 | K160734 | 000 |
| 00841517109172 | K160734 | 000 |