Medical Device Manufacturer · US , Mchenry , IL

General Electric Co.

254 submissions · 254 cleared · Since 1976
254
Total
254
Cleared
0
Denied

General Electric Co. — FDA 510(k) Submissions

General Electric Co. has submitted 254 FDA 510(k) premarket notifications since 1976, of which 254 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Tomography, Computed, System, Nuclear Magnetic Resonance Imaging, System, Imaging, Pulsed Doppler, Ultrasonic, System, Imaging, Pulsed Echo, Ultrasonic, Camera, Scintillation (gamma) . Use the specialty filter in the sidebar to narrow results.

254 devices
1–25 of 254
GE VEO RECONSTRUCTION OPTION
K103489 · JAK System, X-ray,... · Radiology
Sep 2011 287d
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · KGI Densitometer, Bone · Radiology
Sep 2008 44d
GE VIVID E9 ULTRASOUND
K081921 · IYN System, Imaging, Pulsed... · Radiology
Aug 2008 30d
GE LOGIQ P6
K073297 · IYN System, Imaging, Pulsed... · Radiology
Dec 2007 25d
GE ECHOPAC
K072952 · LLZ System, Image Processing,... · Radiology
Nov 2007 29d
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
K072797 · IYO System, Imaging, Pulsed... · Radiology
Oct 2007 16d
MODIFICATION TO GE LOGIQ A3
K072075 · IYN System, Imaging, Pulsed... · Radiology
Aug 2007 30d
GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
K071985 · IYN System, Imaging, Pulsed... · Radiology
Aug 2007 29d
GE LOGIQ WORKS
K063006 · LLZ System, Image Processing,... · Radiology
Nov 2006 31d
GE VOLUSON E8 ULTRASOUND SYSTEM
K061682 · IYO System, Imaging, Pulsed... · Radiology
Jul 2006 27d
GE VIVID - I
K061525 · IYN System, Imaging, Pulsed... · Radiology
Jul 2006 31d
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
K061129 · IYN System, Imaging, Pulsed... · Radiology
Jun 2006 38d
GE LOGIQ P5 AND A5
K060993 · IYN System, Imaging, Pulsed... · Radiology
May 2006 22d
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
K060542 · IYN System, Imaging, Pulsed... · Radiology
Mar 2006 30d
GE VOLUSON I
K053435 · IYN System, Imaging, Pulsed... · Radiology
Dec 2005 7d
GE LOGIQ 7 ULTRASOUND BT05
K052441 · IYN System, Imaging, Pulsed... · Radiology
Sep 2005 15d
GE VIEWPOINT
K050943 · LLZ System, Image Processing,... · Radiology
May 2005 39d
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · KPR System, X-ray, Stationary · Radiology
Apr 2005 21d
GE LOGIQ TWIN
K050126 · IYN System, Imaging, Pulsed... · Radiology
Feb 2005 14d
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
K043112 · LNH System, Nuclear Magnetic... · Radiology
Nov 2004 14d
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · KPS System, Tomography,... · Radiology
Sep 2004 19d
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · IZL System, X-ray, Mobile · Radiology
Jul 2004 12d
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
K041688 · IYN System, Imaging, Pulsed... · Radiology
Jul 2004 16d
GE VIVID 7 BT04
K041552 · IYN System, Imaging, Pulsed... · Radiology
Jul 2004 23d
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444 · LNH System, Nuclear Magnetic... · Radiology
Apr 2004 85d

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