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FUJIFILM Sonosite, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260595Sonosite iLOOK Ultrasound SystemMarch 10, 2026
K253448Sonosite MT Ultrasound SystemNovember 3, 2025
K251106Sonosite LX and Sonosite PX Ultrasound SystemsAugust 29, 2025
K251830Sonosite LX Ultrasound SystemJuly 10, 2025
K233597Sonosite LX Ultrasound SystemDecember 6, 2023
K213763Sonosite PX Ultrasound SystemDecember 27, 2021
K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, SonoSeptember 1, 2020
K200964Sonosite PX Ultrasound SystemMay 8, 2020
K190476FUJIFILM Sonosite Vevo MD Imaging SystemMarch 15, 2019
K183235SonoSite SII Ultrasound SystemFebruary 7, 2019
K180704SonoSite iViz Ultrasound SystemApril 13, 2018
K171437SonoSite X-Porte Ultrasound SystemJune 12, 2017
K162288SonoSite iViz Ultrasound SystemSeptember 8, 2016
K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemAugust 18, 2016
K161119SonoSite iViz Ultrasound SystemMay 13, 2016
K160674Fujifilm Sonosite Vevo MD Imaging SystemApril 19, 2016
K160734SonoSite SII Ultrasound SystemApril 5, 2016
K160406FUJIFILM FC1 Ultrasound SystemMarch 16, 2016
K153626SonoSite Edge II Ultrasound SystemJanuary 20, 2016
K152983FUJIFILM SonoSite iViz Ultrasound SystemNovember 12, 2015