Ge Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GE LIGHTSPEED ACT FP16, GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM, GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
54
Total
54
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ge Medical Systems, Inc. Radiology ✕
54 devices
Cleared
Jun 24, 2009
GE LIGHTSPEED ACT FP16
Radiology
15d
Cleared
Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 /...
Radiology
39d
Cleared
Nov 03, 2004
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6...
Radiology
19d
Cleared
Aug 26, 2004
INNOVA 4100, INNOVA 3100
Radiology
27d
Cleared
Apr 19, 2004
SENOGRAPHIC STEREO
Radiology
90d
Cleared
Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
Radiology
9d
Cleared
May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
Radiology
36d
Cleared
May 06, 2003
CT COLONOGRAPHY
Radiology
161d
Cleared
Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
Radiology
23d
Cleared
Apr 10, 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
Radiology
14d
Cleared
Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
Radiology
14d
Cleared
Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
Radiology
27d
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