Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices
40
Total
39
Cleared
1
Denied
40 devices
Cleared
Oct 16, 2015
GR40CW
Radiology
80d
Cleared
Jul 17, 2015
GUA60A, GU60A-65
Radiology
25d
Cleared
Jun 23, 2015
GF50A
Radiology
26d
Cleared
Apr 02, 2015
GC85A
Radiology
66d
Cleared
Feb 19, 2015
GM60A-32S & GM60A-40S
Radiology
30d
Cleared
Feb 04, 2015
Digital Diagnostic X-ray System (GC80)
Radiology
106d
Cleared
Dec 17, 2014
GM60A-32S, GM60A-40S
Radiology
104d
Cleared
May 29, 2014
XGEO GF50
Radiology
108d
Cleared
May 28, 2014
XGEO GU60A
Radiology
107d
Cleared
May 28, 2014
XGEO GC80
Radiology
107d
Cleared
May 15, 2014
XGEO GR40CW
Radiology
105d
Cleared
Dec 04, 2013
S HEALTH
Cardiovascular
146d
Cleared
Jun 20, 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
Radiology
261d
Cleared
Jun 07, 2013
XGEO GU60
Radiology
248d
Cleared
Jan 18, 2013
XGEO GC80
Radiology
108d