FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990226 |
01/25/1999 |
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW |
GE MEDICAL SYSTEMS, INC. |
| K000516 |
02/16/2000 |
GE LOGIQ 700 |
GE MEDICAL SYSTEMS, INC. |
| K000695 |
03/01/2000 |
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K030934 |
03/25/2003 |
GE LOGIQ 9 MODEL 2375600 |
GE MEDICAL SYSTEMS, INC. |
| K001267 |
04/20/2000 |
GE SYSTEM FIVE |
GE MEDICAL SYSTEMS, INC. |
| K091673 |
06/09/2009 |
GE LIGHTSPEED ACT FP16 |
GE MEDICAL SYSTEMS, INC. |
| K992208 |
06/30/1999 |
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K993364 |
10/06/1999 |
GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
| K993365 |
10/06/1999 |
GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
| K003931 |
12/20/2000 |
VIVID 7 WITH SONOPAC, MODEL FB0008XX |
GE MEDICAL SYSTEMS, INC. |
| K010641 |
03/05/2001 |
GE CT-PET SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K003849 |
12/12/2000 |
GE ADVANCE NXI PET SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K012389 |
07/27/2001 |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K012385 |
07/27/2001 |
HISPEED X/I SMART GANTRY OPTION |
GE MEDICAL SYSTEMS, INC. |
| K030495 |
02/19/2003 |
3.0T TORSO PHASED ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
| K030953 |
03/27/2003 |
GE 3.0T GENERAL PURPOSE FLEX COIL |
GE MEDICAL SYSTEMS, INC. |
| K031209 |
04/17/2003 |
GE 1.5T 8 CHANNEL TORSO COIL |
GE MEDICAL SYSTEMS, INC. |
| K991629 |
05/11/1999 |
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C |
GE MEDICAL SYSTEMS, INC. |
| K022310 |
07/17/2002 |
ADVANTAGE WINDOWS X-RAY/MR FUSION |
GE MEDICAL SYSTEMS, INC. |
| K012313 |
07/23/2001 |
CT COLONOGRAPHY/NAVIGATOR2 |
GE MEDICAL SYSTEMS, INC. |
| K042844 |
10/15/2004 |
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL |
GE MEDICAL SYSTEMS, INC. |
| K040125 |
01/20/2004 |
SENOGRAPHIC STEREO |
GE MEDICAL SYSTEMS, INC. |
| K000300 |
01/31/2000 |
LIGHTSPEED 2.0CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K010336 |
02/05/2001 |
ADVANTAGE WINDOWS CT/PET FUSION |
GE MEDICAL SYSTEMS, INC. |
| K990550 |
02/22/1999 |
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K021491 |
05/09/2002 |
HISPEED DUAL |
GE MEDICAL SYSTEMS, INC. |
| K991716 |
05/20/1999 |
HISPEED NX/I CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K011604 |
05/24/2001 |
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI |
GE MEDICAL SYSTEMS, INC. |
| K972296 |
06/19/1997 |
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K992135 |
06/24/1999 |
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K972399 |
06/26/1997 |
ADVANTAGE WINDOWS VOLUME RENDERING OPTION |
GE MEDICAL SYSTEMS, INC. |
| K001946 |
06/26/2000 |
NEUROVASCULAR ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
| K022240 |
07/11/2002 |
MOBILE MILLENNIUM MG SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K022322 |
07/17/2002 |
INNOVA AND INNOVA 2000 S |
GE MEDICAL SYSTEMS, INC. |
| K972704 |
07/18/1997 |
KINEMATIC POSITIONERS |
GE MEDICAL SYSTEMS, INC. |
| K042053 |
07/30/2004 |
INNOVA 4100, INNOVA 3100 |
GE MEDICAL SYSTEMS, INC. |
| K982772 |
08/07/1998 |
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
| K992746 |
08/16/1999 |
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K973270 |
09/02/1997 |
LEG'MAP OPTION |
GE MEDICAL SYSTEMS, INC. |
| K973368 |
09/08/1997 |
STRAIT'MAP OPTION |
GE MEDICAL SYSTEMS, INC. |
| K993037 |
09/09/1999 |
LCV+ VERSION 2 |
GE MEDICAL SYSTEMS, INC. |
| K993090 |
09/16/1999 |
SILHOUETTE FC |
GE MEDICAL SYSTEMS, INC. |
| K033244 |
10/07/2003 |
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION |
GE MEDICAL SYSTEMS, INC. |
| K993645 |
10/28/1999 |
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K993665 |
10/29/1999 |
LEGEND CRF FLUORO AND RAD SYSTEM |
GE MEDICAL SYSTEMS, INC. |
| K993791 |
11/09/1999 |
CT PERFUSION OPTION |
GE MEDICAL SYSTEMS, INC. |
| K993792 |
11/09/1999 |
SMART VESSEL ANALYSIS (SMART VA) OPTION |
GE MEDICAL SYSTEMS, INC. |
| K003573 |
11/20/2000 |
DIFFUSION TENSOR IMAGING OPTION |
GE MEDICAL SYSTEMS, INC. |
| K023943 |
11/26/2002 |
CT COLONOGRAPHY |
GE MEDICAL SYSTEMS, INC. |
| K024137 |
12/16/2002 |
JUPITER PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS, INC. |
| K024200 |
12/20/2002 |
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) |
GE MEDICAL SYSTEMS, INC. |
| K023178 |
09/23/2002 |
INNOVA 4100 |
GE MEDICAL SYSTEMS, INC. |
| K970628 |
02/19/1997 |
GE ADVANTAGE DIGITIZER WORKSTATION |
GE MEDICAL SYSTEMS, INC. |
| K082104 |
07/25/2008 |
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM |
GE MEDICAL SYSTEMS, INC. |
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