GE Medical Systems - FDA 510(k) Cleared Devices
169
Total
166
Cleared
0
Denied
160 devices
Cleared
Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
Radiology
25d
Cleared
Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
Radiology
30d
Cleared
Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
Radiology
80d
Cleared
Apr 03, 2002
SMARTSCORE 3.5
Radiology
12d
Cleared
Mar 26, 2002
CARD IQ ANALYSIS II
Radiology
14d
Cleared
Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
Radiology
15d
Cleared
Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
Radiology
80d
Cleared
Jan 10, 2002
GE LOGIQ 5
Radiology
29d
Cleared
Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
Radiology
85d
Cleared
Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
Radiology
13d
Cleared
Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
Radiology
14d
Cleared
Oct 30, 2001
CARDIQ FUNCTION
Radiology
15d
Cleared
Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
Radiology
20d
Cleared
Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
Radiology
29d
Cleared
Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
Radiology
15d
Cleared
Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
Radiology
21d
Cleared
Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
Radiology
14d
Cleared
May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
Radiology
30d
Cleared
Apr 11, 2001
FIESTA IMAGING OPTION
Radiology
197d
Cleared
Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
Radiology
132d
Cleared
Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
Radiology
82d
Cleared
Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
Radiology
68d
Cleared
Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
Radiology
58d
Cleared
Nov 17, 2000
CT CORD IQ OPTION 1.0
Radiology
15d
Cleared
Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
Radiology
70d
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