The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite X-porte Ultrasound System.
| Device ID | K171437 |
| 510k Number | K171437 |
| Device Name: | SonoSite X-Porte Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FujiFilm SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Jordan Lydia Grimmer |
| 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 | 2017-05-16 |
| Decision Date | 2017-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517106249 | K171437 | 000 |
| 00841517106225 | K171437 | 000 |
| 00841517106102 | K171437 | 000 |
| 00841517106126 | K171437 | 000 |
| 00841517111748 | K171437 | 000 |
| 00841517111724 | K171437 | 000 |
| 00841517111816 | K171437 | 000 |
| 00841517111793 | K171437 | 000 |
| 00841517111755 | K171437 | 000 |