The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Fujifilm Fc1 Ultrasound System.
| Device ID | K160406 |
| 510k Number | K160406 |
| Device Name: | FUJIFILM FC1 Ultrasound 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 | 2016-02-16 |
| Decision Date | 2016-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517103965 | K160406 | 000 |
| 00841517103996 | K160406 | 000 |
| 00841517107208 | K160406 | 000 |
| 00841517106461 | K160406 | 000 |
| 00841517100940 | K160406 | 000 |
| 00841517101169 | K160406 | 000 |
| 00841517101176 | K160406 | 000 |
| 00841517102111 | K160406 | 000 |
| 00841517102210 | K160406 | 000 |
| 00841517102722 | K160406 | 000 |
| 00841517103507 | K160406 | 000 |
| 00841517103514 | K160406 | 000 |
| 00841517109547 | K160406 | 000 |