Medical Device Manufacturer · US , Wauwatosa , WI

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

12 submissions · 12 cleared · Since 2016
12
Total
12
Cleared
0
Denied

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — FDA 510(k) Submissions

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has submitted 12 FDA 510(k) premarket notifications since 2016, of which 12 received clearance as substantially equivalent to a predicate device.

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

12 devices
1–12 of 12
Vivid iq
K221148 · IYN System, Imaging, Pulsed... · Radiology
Jul 2022 89d
ViewPoint 6
K203677 · LLZ System, Image Processing,... · Radiology
Jan 2021 29d
LOGIQ E10
K200158 · IYN System, Imaging, Pulsed... · Radiology
Apr 2020 86d
GEHC DXA Bone Densitometers with enCORE version 18
K191112 · KGI Densitometer, Bone · Radiology
Sep 2019 146d
Vivid T8, Vivid T9
K181934 · IYN System, Imaging, Pulsed... · Radiology
Nov 2018 110d
Aria
K180782 · KGI Densitometer, Bone · Radiology
Apr 2018 25d
Venue
K170714 · IYN System, Imaging, Pulsed... · Radiology
Jun 2017 104d
Vivid S60N, Vivid S70N
K170878 · IYN System, Imaging, Pulsed... · Radiology
Jun 2017 82d
GE Lunar DXA Bone Densitometers with enCORE version 17
K161682 · KGI Densitometer, Bone · Radiology
Dec 2016 168d
Vscan Extend
K161588 · IYN System, Imaging, Pulsed... · Radiology
Aug 2016 84d
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
K161224 · IYN System, Imaging, Pulsed... · Radiology
Aug 2016 98d
LOGIQ V1/ LOGIQ V2
K153037 · IYN System, Imaging, Pulsed... · Radiology
Jan 2016 77d
Filters
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