GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC - FDA 5...
13
Total
13
Cleared
0
Denied
FDA 510(k) cleared devices by GE Medical Systems Ultrasound &... Radiology ✕
13 devices
Cleared
Mar 27, 2026
Automated Aortic Stenosis Software (AutoAS)
Radiology
95d
Cleared
Jul 18, 2022
Vivid iq
Radiology
89d
Cleared
Jan 15, 2021
ViewPoint 6
Radiology
29d
Cleared
Apr 17, 2020
LOGIQ E10
Radiology
86d
Cleared
Sep 19, 2019
GEHC DXA Bone Densitometers with enCORE version 18
Radiology
146d
Cleared
Nov 06, 2018
Vivid T8, Vivid T9
Radiology
110d
Cleared
Apr 20, 2018
Aria
Radiology
25d
Cleared
Jun 21, 2017
Venue
Radiology
104d
Cleared
Jun 14, 2017
Vivid S60N, Vivid S70N
Radiology
82d
Cleared
Dec 02, 2016
GE Lunar DXA Bone Densitometers with enCORE version 17
Radiology
168d
Cleared
Aug 31, 2016
Vscan Extend
Radiology
84d
Cleared
Aug 05, 2016
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
Radiology
98d