Medical Device Manufacturer · US , Bothell , WA

FUJIFILM Sonosite, Inc.

25 submissions · 25 cleared · Since 2013
25
Total
25
Cleared
0
Denied

FUJIFILM Sonosite, Inc. — FDA 510(k) Submissions

FUJIFILM Sonosite, Inc. has submitted 25 FDA 510(k) premarket notifications since 2013, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
Sonosite iLOOK Ultrasound System
K260595 · IYN System, Imaging, Pulsed... · Radiology
Mar 2026 15d
Sonosite MT Ultrasound System
K253448 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 32d
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · IYN System, Imaging, Pulsed... · Radiology
Aug 2025 140d
Sonosite LX Ultrasound System
K251830 · IYN System, Imaging, Pulsed... · Radiology
Jul 2025 27d
Sonosite LX Ultrasound System
K233597 · IYN System, Imaging, Pulsed... · Radiology
Dec 2023 28d
Sonosite PX Ultrasound System
K213763 · IYN System, Imaging, Pulsed... · Radiology
Dec 2021 26d
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 System
K202160 · IYN System, Imaging, Pulsed... · Radiology
Sep 2020 29d
Sonosite PX Ultrasound System
K200964 · IYN System, Imaging, Pulsed... · Radiology
May 2020 28d
FUJIFILM Sonosite Vevo MD Imaging System
K190476 · IYN System, Imaging, Pulsed... · Radiology
Mar 2019 16d
SonoSite SII Ultrasound System
K183235 · IYN System, Imaging, Pulsed... · Radiology
Feb 2019 79d
SonoSite iViz Ultrasound System
K180704 · IYN System, Imaging, Pulsed... · Radiology
Apr 2018 25d
SonoSite X-Porte Ultrasound System
K171437 · IYN System, Imaging, Pulsed... · Radiology
Jun 2017 27d
SonoSite iViz Ultrasound System
K162288 · IYN System, Imaging, Pulsed... · Radiology
Sep 2016 24d
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · IYN System, Imaging, Pulsed... · Radiology
Aug 2016 24d
SonoSite iViz Ultrasound System
K161119 · IYN System, Imaging, Pulsed... · Radiology
May 2016 23d
Fujifilm Sonosite Vevo MD Imaging System
K160674 · IYN System, Imaging, Pulsed... · Radiology
Apr 2016 40d
SonoSite SII Ultrasound System
K160734 · IYN System, Imaging, Pulsed... · Radiology
Apr 2016 19d
FUJIFILM FC1 Ultrasound System
K160406 · IYN System, Imaging, Pulsed... · Radiology
Mar 2016 29d
SonoSite Edge II Ultrasound System
K153626 · IYN System, Imaging, Pulsed... · Radiology
Jan 2016 33d
FUJIFILM SonoSite iViz Ultrasound System
K152983 · IYN System, Imaging, Pulsed... · Radiology
Nov 2015 34d
FUJIFILM SonoSite X-Porte Ultrasound System
K152209 · IYN System, Imaging, Pulsed... · Radiology
Aug 2015 12d
X-PORTE ULTRASOUND SYSTEM
K142017 · IYN System, Imaging, Pulsed... · Radiology
Aug 2014 28d
SONOSITE EDGE ULTRASOUND SYSTEM
K133454 · IYN System, Imaging, Pulsed... · Radiology
Dec 2013 34d
X-PORTE ULTRASOUND SYSTEM
K133134 · IYN System, Imaging, Pulsed... · Radiology
Nov 2013 34d
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K130173 · IYN System, Imaging, Pulsed... · Radiology
Mar 2013 60d
Filters
All25 Radiology 25