The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Fujifilm Sonosite Vevo Md Imaging System.
| Device ID | K160674 |
| 510k Number | K160674 |
| Device Name: | Fujifilm Sonosite Vevo MD Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SONOSITE, INC. 21919 30TH DRIVE SE Bothell, WA 98021 -3904 |
| Contact | Scott Paulson |
| 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 | 2016-03-10 |
| Decision Date | 2016-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517104696 | K160674 | 000 |
| 00841517102302 | K160674 | 000 |
| 00841517100766 | K160674 | 000 |
| 00841517100759 | K160674 | 000 |
| 00841517100742 | K160674 | 000 |
| 00841517100735 | K160674 | 000 |
| 00841517100728 | K160674 | 000 |
| 00841517100711 | K160674 | 000 |
| 00841517100704 | K160674 | 000 |
| 00841517100698 | K160674 | 000 |
| 00841517109790 | K160674 | 000 |
| 00841517102319 | K160674 | 000 |
| 00841517102326 | K160674 | 000 |
| 00841517102333 | K160674 | 000 |
| 00841517104689 | K160674 | 000 |
| 00841517104672 | K160674 | 000 |
| 00841517104535 | K160674 | 000 |
| 00841517104528 | K160674 | 000 |
| 00841517104511 | K160674 | 000 |
| 00841517103248 | K160674 | 000 |
| 00841517102548 | K160674 | 000 |
| 00841517102524 | K160674 | 000 |
| 00841517102357 | K160674 | 000 |
| 00841517102340 | K160674 | 000 |
| 00841517110123 | K160674 | 000 |