Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FUJIFILM Sonosite, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories1
Latest FDA decision2026-03-10
TypeNumberDevice NameCodeDateActions
510(k) K260595 Sonosite iLOOK Ultrasound SystemIYN2026-03-10 View
510(k) K253448 Sonosite MT Ultrasound SystemIYN2025-11-03 View
510(k) K251106 Sonosite LX and Sonosite PX Ultrasound SystemsIYN2025-08-29 View
510(k) K251830 Sonosite LX Ultrasound SystemIYN2025-07-10 View
510(k) K233597 Sonosite LX Ultrasound SystemIYN2023-12-06 View
510(k) K213763 Sonosite PX Ultrasound SystemIYN2021-12-27 View
510(k) K202160 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound SystemIYN2020-09-01 View
510(k) K200964 Sonosite PX Ultrasound SystemIYN2020-05-08 View
510(k) K190476 FUJIFILM Sonosite Vevo MD Imaging SystemIYN2019-03-15 View
510(k) K183235 SonoSite SII Ultrasound SystemIYN2019-02-07 View
510(k) K180704 SonoSite iViz Ultrasound SystemIYN2018-04-13 View
510(k) K171437 SonoSite X-Porte Ultrasound SystemIYN2017-06-12 View
510(k) K162288 SonoSite iViz Ultrasound SystemIYN2016-09-08 View
510(k) K162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemIYN2016-08-18 View
510(k) K161119 SonoSite iViz Ultrasound SystemIYN2016-05-13 View
510(k) K160674 Fujifilm Sonosite Vevo MD Imaging SystemIYN2016-04-19 View
510(k) K160734 SonoSite SII Ultrasound SystemIYN2016-04-05 View
510(k) K160406 FUJIFILM FC1 Ultrasound SystemIYN2016-03-16 View
510(k) K153626 SonoSite Edge II Ultrasound SystemIYN2016-01-20 View
↑