Medical Device Manufacturer · US , Milwaukee , WI

GE Medical Systems

169 submissions · 166 cleared · Since 1989
169
Total
166
Cleared
0
Denied

GE Medical Systems — FDA 510(k) Submissions

GE Medical Systems has submitted 169 FDA 510(k) premarket notifications since 1989, of which 166 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nuclear Magnetic Resonance Imaging, System, X-ray, Tomography, Computed, System, Tomography, Computed, Emission, Coil, Magnetic Resonance, Specialty, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

169 devices
1–25 of 169
Venue Fit
K220848 · IYN System, Imaging, Pulsed... · Radiology
Jun 2022 96d
Venue
K220851 · IYN System, Imaging, Pulsed... · Radiology
Jun 2022 96d
Vivid E80, Vivid E90, Vivid E95
K173341 · IYN System, Imaging, Pulsed... · Radiology
Nov 2017 9d
IDEAL IQ SOFTWARE OPTION
K103411 · LNH System, Nuclear Magnetic... · Radiology
Mar 2011 120d
CARDIQ EXPRESS VERSION 2.0
K073138 · JAK System, X-ray,... · Radiology
Feb 2008 111d
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH System, Nuclear Magnetic... · Radiology
Nov 2005 22d
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · KPS System, Tomography,... · Radiology
Sep 2005 21d
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
K051673 · LLZ System, Image Processing,... · Radiology
Jul 2005 25d
GE VIVID 7 WITH OR WITHOUT SUFFIX
K051449 · IYN System, Imaging, Pulsed... · Radiology
Jun 2005 14d
GE DISCOVERY VCT SYSTEM
K050559 · KPS System, Tomography,... · Radiology
Mar 2005 14d
ADVANCED LUNG ANALYSIS II
K042694 · OEB Lung Computed Tomography... · Radiology
Nov 2004 49d
GE DISCOVERY ST SYSTEM
K041220 · KPS System, Tomography,... · Radiology
Jun 2004 36d
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · KPS System, Tomography,... · Radiology
Apr 2004 72d
INNOVA 3100
K031637 · OWB Interventional... · Radiology
Aug 2003 87d
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · MOS Coil, Magnetic Resonance,... · Radiology
Jul 2003 28d
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · LNH System, Nuclear Magnetic... · Radiology
Jul 2003 9d
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · LNH System, Nuclear Magnetic... · Radiology
May 2003 11d
CARD EP
K031261 · JAK System, X-ray,... · Radiology
May 2003 15d
GE PROPELLER IMAGING OPTION FOR MRI
K031230 · LNH System, Nuclear Magnetic... · Radiology
May 2003 14d
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · JAK System, X-ray,... · Radiology
Mar 2003 28d
GE DISCOVERY LS SYSTEM
K023988 · KPS System, Tomography,... · Radiology
Feb 2003 64d
CENTRICITY PACS PLUS
K023557 · LLZ System, Image Processing,... · Radiology
Nov 2002 15d
EXTRA LARGE BODY COIL
K023442 · MOS Coil, Magnetic Resonance,... · Radiology
Nov 2002 21d
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · JAK System, X-ray,... · Radiology
Oct 2002 16d
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · JAK System, X-ray,... · Radiology
Sep 2002 15d

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