Medical Device Manufacturer · US , Bothell , WA

FUJIFILM Sonosite, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2013

Recent clearances: Sonosite iLOOK Ultrasound System, Sonosite MT Ultrasound System, Sonosite LX and Sonosite PX Ultrasound Systems

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25
Total
25
Cleared
0
Denied

FDA 510(k) Regulatory Record - FUJIFILM Sonosite, Inc. Radiology ✕

25 devices
1-12 of 25
Cleared Mar 10, 2026
Sonosite iLOOK Ultrasound System
K260595 · IYN
Radiology · 15d
Cleared Nov 03, 2025
Sonosite MT Ultrasound System
K253448 · IYN
Radiology · 32d
Cleared Aug 29, 2025
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · IYN
Radiology · 140d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
Radiology · 27d
Cleared Dec 06, 2023
Sonosite LX Ultrasound System
K233597 · IYN
Radiology · 28d
Cleared Dec 27, 2021
Sonosite PX Ultrasound System
K213763 · IYN
Radiology · 26d
Cleared Sep 01, 2020
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz...
K202160 · IYN
Radiology · 29d
Cleared May 08, 2020
Sonosite PX Ultrasound System
K200964 · IYN
Radiology · 28d
Cleared Mar 15, 2019
FUJIFILM Sonosite Vevo MD Imaging System
K190476 · IYN
Radiology · 16d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
Radiology · 79d
Cleared Apr 13, 2018
SonoSite iViz Ultrasound System
K180704 · IYN
Radiology · 25d
Cleared Jun 12, 2017
SonoSite X-Porte Ultrasound System
K171437 · IYN
Radiology · 27d
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