GE Medical Systems - FDA 510(k) Cleared Devices
Recent clearances: AIR Recon DL, Venue Fit, Venue
170
Total
167
Cleared
0
Denied
FDA 510(k) Regulatory Record - GE Medical Systems Radiology ✕
161 devices
Cleared
Aug 13, 2026
AIR Recon DL
Radiology
258d
Cleared
Jun 27, 2022
Venue Fit
Radiology
96d
Cleared
Jun 27, 2022
Venue
Radiology
96d
Cleared
Nov 02, 2017
Vivid E80, Vivid E90, Vivid E95
Radiology
9d
Cleared
Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
Radiology
120d
Cleared
Feb 26, 2008
CARDIQ EXPRESS VERSION 2.0
Radiology
111d
Cleared
Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
Radiology
22d
Cleared
Sep 27, 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
Radiology
21d
Cleared
Jul 18, 2005
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
Radiology
25d
Cleared
Jun 16, 2005
GE VIVID 7 WITH OR WITHOUT SUFFIX
Radiology
14d
Cleared
Mar 17, 2005
GE DISCOVERY VCT SYSTEM
Radiology
14d
Cleared
Nov 18, 2004
ADVANCED LUNG ANALYSIS II
Radiology
49d
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