FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

719 results for "GE Medical Systems"
313–336 of 719
Search insights Median review: 81d Cleared: 100% Top manufacturer: GE Medical Systems Lead specialty: Radiology
Cleared Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 /...
K082104 · JAK
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Aug 15, 2008
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
K082185 · IYO
Ge Medical Systems Ultrasound and...
Radiology · 14d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916 · LNH
Ge Medical Systems, LLC
Radiology · 15d
Cleared Jul 15, 2008
MAC 1600 ECG ANALYSIS SYSTEM
K081437 · DPS
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared Jun 20, 2008
APEXPRO TELEMETRY SYSTEMS
K080251 · MHX
Ge Medical Systems Information...
Cardiovascular · 141d
Cleared Jun 12, 2008
OPTIMA PET/CT 560
K081496 · KPS
Ge Medical Systems, LLC
Radiology · 14d
Cleared Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
K081028 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Mar 24, 2008
DASH 2500 PATIENT MONITOR
K080157 · MHX
Ge Medical Systems Information...
Cardiovascular · 61d
Cleared Feb 26, 2008
CARDIQ FUNCTION XPRESS
K073153 · JAK
GE Medical Systems SCS
Radiology · 110d
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