Company ยท US
FUJIFILM Sonosite, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 25 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2026 | K260595 | Sonosite iLOOK Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Nov 3, 2025 | K253448 | Sonosite MT Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Aug 29, 2025 | K251106 | Sonosite LX and Sonosite PX Ultrasound Systems FUJIFILM Sonosite, Inc. | IYN |
| Jul 10, 2025 | K251830 | Sonosite LX Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Dec 6, 2023 | K233597 | Sonosite LX Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Dec 27, 2021 | K213763 | Sonosite PX Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Sep 1, 2020 | K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultraso FUJIFILM Sonosite, Inc. | IYN |
| May 8, 2020 | K200964 | Sonosite PX Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Mar 15, 2019 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System FUJIFILM Sonosite, Inc. | IYN |
| Feb 7, 2019 | K183235 | SonoSite SII Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Apr 13, 2018 | K180704 | SonoSite iViz Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Jun 12, 2017 | K171437 | SonoSite X-Porte Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Sep 8, 2016 | K162288 | SonoSite iViz Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Aug 18, 2016 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| May 13, 2016 | K161119 | SonoSite iViz Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Apr 19, 2016 | K160674 | Fujifilm Sonosite Vevo MD Imaging System FUJIFILM Sonosite, Inc. | IYN |
| Apr 5, 2016 | K160734 | SonoSite SII Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Mar 16, 2016 | K160406 | FUJIFILM FC1 Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Jan 20, 2016 | K153626 | SonoSite Edge II Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Nov 12, 2015 | K152983 | FUJIFILM SonoSite iViz Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Aug 19, 2015 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System FUJIFILM Sonosite, Inc. | IYN |
| Aug 22, 2014 | K142017 | X-PORTE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. | IYN |
| Dec 16, 2013 | K133454 | SONOSITE EDGE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. | IYN |
| Nov 4, 2013 | K133134 | X-PORTE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. | IYN |
| Mar 25, 2013 | K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||