Ge Medical Systems, LLC - FDA 510(k) Cleared Devices
103
Total
103
Cleared
0
Denied
103 devices
Cleared
Apr 12, 2019
Deep Learning Image Reconstruction
Radiology
144d
Cleared
Feb 13, 2019
SnapShot Freeze 2
Radiology
90d
Cleared
Jan 18, 2019
SIGNA Premier
Radiology
59d
Cleared
Sep 06, 2018
Optima XR240amx
Radiology
20d
Cleared
Apr 11, 2018
PET Digital Gating
Radiology
65d
Cleared
Jan 12, 2018
Optima XR240amx, AutoGrid
Radiology
52d
Cleared
Jul 14, 2017
SIGNA Premier
Radiology
88d
Cleared
Apr 20, 2017
HyperSense
Radiology
203d
Cleared
Mar 17, 2017
Discovery MR750 3.0T
Radiology
109d
Cleared
Feb 14, 2017
SIGNA PET/MR
Radiology
54d
Cleared
Dec 16, 2016
Revolution CT
Radiology
30d
Cleared
Nov 18, 2016
HyperBand
Radiology
81d
Cleared
Nov 15, 2016
Optima XR240amx
Radiology
19d
Cleared
Aug 31, 2016
MAGiC
Radiology
104d
Cleared
Aug 11, 2016
Discovery MI
Radiology
65d
Cleared
Jun 09, 2016
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima...
Radiology
98d
Cleared
Aug 14, 2015
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
Radiology
85d
Cleared
Jul 29, 2015
GenIQ
Radiology
246d
Cleared
Mar 24, 2015
Customer Remote Console (CRC)
Radiology
55d
Cleared
Dec 05, 2014
Discovery MR750 3.0T
Radiology
102d
Cleared
Nov 24, 2014
SIGNA PET/MR
Radiology
115d
Cleared
Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA...
Radiology
57d
Cleared
Sep 25, 2014
Optima XR200amx, Optima XR220amx
Radiology
30d
Cleared
Sep 18, 2014
CORTEX ID SUITE
Radiology
146d
Cleared
Sep 18, 2014
DISCOVERY IQ
Radiology
106d
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