FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

710 results for "GE Medical Systems"
313–336 of 710
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Feb 26, 2008
CARDIQ EXPRESS VERSION 2.0
K073138 · JAK
GE Medical Systems
Radiology · 111d
Cleared Jan 31, 2008
VENTRI 1.1
K080124 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Jan 11, 2008
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
K073462 · MHX
Ge Medical Systems Information...
Cardiovascular · 32d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167 · LNH
Ge Medical Systems, LLC
Radiology · 56d
Cleared Dec 19, 2007
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
K073408 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 15d
Cleared Nov 29, 2007
CARESCAPE V100
K073203 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Nov 19, 2007
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998 · LNH
Ge Medical Systems, LLC
Radiology · 8d
Cleared Sep 21, 2007
MODIFICATION TO: UNITY NETWORK ID
K071982 · MWI
Ge Medical Systems Information...
Cardiovascular · 64d
Cleared Sep 14, 2007
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K072439 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 15d
Cleared Jun 27, 2007
GE LUNAR BODY COMPOSITION SOFTWARE
K071570 · KGI
Ge Medical Systems Lunar
Radiology · 19d
Cleared May 11, 2007
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
K071073 · MHX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared Mar 16, 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976 · DSI
Ge Medical Systems Information...
Cardiovascular · 168d
Cleared Aug 04, 2006
12 RL ALGORITHM
K060307 · DRT
Ge Medical Systems Information...
Cardiovascular · 178d
Cleared Aug 01, 2006
12SL ECG ANALYSIS PROGRAM
K060833 · MHX
Ge Medical Systems Information...
Cardiovascular · 127d
Cleared Jul 12, 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
K061817 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 07, 2006
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA...
K061163 · OWB
Ge Medical Systems, LLC
Radiology · 42d
Cleared Jun 07, 2006
PRECISION THUNIS 800+
K061028 · JAA
Ge Medical Systems, LLC
Radiology · 55d
Cleared Apr 19, 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K060052 · JAK
Ge Medical Systems, LLC
Radiology · 103d
Cleared Apr 19, 2006
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K053356 · DXJ
Ge Medical Systems Information...
Cardiovascular · 138d
Cleared Apr 07, 2006
MACTRODE 3
K060661 · DRX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared Feb 22, 2006
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
K060259 · OWB
Ge Medical Systems, LLC
Radiology · 21d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH
GE Medical Systems
Radiology · 22d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978 · LNH
Ge Medical Systems, LLC
Radiology · 16d