FUJIFILM Sonosite, Inc.
FUJIFILM Sonosite, Inc. appears in FDA public data with 0 recalls, 25 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Mar 10, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 25
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | Mar 10, 2026 |
| K253448 | Sonosite MT Ultrasound System | Nov 3, 2025 |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | Aug 29, 2025 |
| K251830 | Sonosite LX Ultrasound System | Jul 10, 2025 |
| K233597 | Sonosite LX Ultrasound System | Dec 6, 2023 |
| K213763 | Sonosite PX Ultrasound System | Dec 27, 2021 |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sono | Sep 1, 2020 |
| K200964 | Sonosite PX Ultrasound System | May 8, 2020 |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | Mar 15, 2019 |
| K183235 | SonoSite SII Ultrasound System | Feb 7, 2019 |
| K180704 | SonoSite iViz Ultrasound System | Apr 13, 2018 |
| K171437 | SonoSite X-Porte Ultrasound System | Jun 12, 2017 |
| K162288 | SonoSite iViz Ultrasound System | Sep 8, 2016 |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | Aug 18, 2016 |
| K161119 | SonoSite iViz Ultrasound System | May 13, 2016 |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | Apr 19, 2016 |
| K160734 | SonoSite SII Ultrasound System | Apr 5, 2016 |
| K160406 | FUJIFILM FC1 Ultrasound System | Mar 16, 2016 |
| K153626 | SonoSite Edge II Ultrasound System | Jan 20, 2016 |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | Nov 12, 2015 |