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LNH

1,101 FDA 510(k) clearances · Product code

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RecordFirmDate
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL (K141977)Siemens Medical Solutions USA, Inc.2014-11-19
SUPERNOVA C5 MRI SYSTEM (K131737)Liaoning Kampo Medical System Co., Ltd.2014-10-23
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra (K142515)Siemens Medical Solutions USA, Inc.2014-10-08
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)Ge Medical Systems, LLC2014-09-26
VANTAGE ELAN (K141472)Toshiba America Medical Systems, In.C2014-09-19
LCD MONITOR (K140956)Nordicneurolab2014-08-07
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE (K133670)Neocoil, LLC2014-07-24
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK (K133848)Heartvista, Inc.2014-06-25
MR ELASTOGRAPHY (K140666)Philips Medical Systems Nederland B.V.2014-06-13
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT (K132381)Clearmri Solutions, Inc.2014-04-04
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE (K140253)Siemens Medical Solutions USA, Inc.2014-03-20
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM (K131896)Suzhou Anke Medical System Co., Ltd.2014-02-28
MDIXON-QUANT (K133526)Philips Medical Systems Nederland B.V.2014-02-12
IMRI 1.5T AND IMRI 3T S (K133692)Imris, Inc.2014-02-10
M2 WRIST 2 MRI SYSTEM (K130692)Aspect Imaging, Ltd.2014-01-14
G-SCAN BRIO (K133490)Esaote, S.p.A.2013-12-30
HEPAFAT SCAN (K122035)Resonance Health Analysis Services Pty, Ltd.2013-12-13
S-SCAN (K131996)Esaote, S.p.A.2013-12-13
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A (K133435)Siemens Medical Solutions USA, Inc.2013-12-12
MAGNETOM PRISMA, MAGNETOM PRISMA FIT (K132119)Siemens Medical Solutions USA, Inc.2013-11-22
MAGNETOM AERA (K132951)Siemens Medical Solutions USA, Inc.2013-11-15
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T (K132376)Ge Healthcare (Ge Medical Systems, LLC)2013-11-15
QUIET/SILENT SCANNING SUITE (K132831)Siemens Medical Solutions USA, Inc.2013-11-01
VANTAGE TITAN 3T (K132160)Toshibamedical Systems Corporation2013-10-16
SWIP (K131241)Philips Medical Systems Nederland B.V.2013-08-30
ELIXBO PM545 (K130658)Xbo Medical Systems Co., Ltd.2013-07-19
DISCOVERY MR750W 3.0T (K130115)Ge Medical Systems, LLC2013-05-23
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT (K130885)Siemens Medical Solutions USA, Inc.2013-05-17
MAGNETOM SKYRA (K123510)Siemens Medical Solutions USA, Inc.2013-05-17
OPTIMA MR450W (K123522)Ge Healthcare (Ge Medical Systems, LLC)2013-03-13
MAGNETOM ESSENZA WITH SYNGO MR D14 (K130262)Siemens Medical Solutions USA, Inc.2013-03-01
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN (K123938)Siemens Medical Solutions USA, Inc.2013-02-12
M2 WRIST MRI SYSTEM (K120701)Aspect Imaging, Ltd.2013-02-07
BRIVO MR355, OPTIMA MR360 (K123417)Ge Hangwei Medical Systems Co., Ltd.2013-01-17
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (K122613)Toshiba America Medical Systems, In.C2012-12-13
MAVRIC SL (K113394)Ge Medical Systems, LLC2012-12-11
MRJ 3300 (K122034)Paramed S.R.L.2012-12-06
OPTIMA MR 430S (K123068)Ge Medical Systems, LLC2012-11-13
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434)Siemens Medi Cal Solutions, Inc.2012-11-05
PRISM ACQUIRE PRISM PROCESS PRISM VIEW (K122026)Prism Clinical Imaging, Inc.2012-09-21
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT (K121676)Ge Medical Systems, LLC2012-09-20
IMRIS ONCOLOGY PACKAGE (K121997)Imris, Inc.2012-08-10
G-SCAN BRIO (K122006)Esaote, S.p.A.2012-08-06
MAGNETOM SPECTRA (K121160)Siemens Medical Solutions USA, Inc.2012-07-16
S-SCAN (K121650)Esaote, S.p.A.2012-07-09
BELLYBOARD, SBRT ACCESSORIES (K121545)Medtec Inc. Dba Civco Medical Solutions2012-06-08
VANTAGE TITAN (K120638)Toshibamedical Systems Corporation2012-06-01
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE (K121239)Optoacoustics, Ltd.2012-05-24
VANTAGE TITAN 3T (K120487)Toshibamedical Systems Corporation2012-05-23
MRI SYTEMS (K113281)Shenzhen Anke High-Tech Co., Ltd.2012-05-17
ECHOSTAR SPICA 1.5T MR SYSTEM (K113511)Alltech Medical Systems America, Inc.2012-05-02
ECHELON OVAL MRI SYSTEM (K113145)Hitachi Medical Systems America, Inc.2012-05-01
SPEEDUP SOFTWARE OPTION (K120748)Esaote, S.p.A.2012-05-01
BRIVO MR355 (K120778)Ge Hangwei Medical Systems Co., Ltd.2012-03-27
VANTAGE TITAN 3T (K113093)Toshibamedical Systems Corporation2012-01-13
OPTIMA MR450W (K113490)Ge Medical Systems, LLC2012-01-13
VISIA DYNAMIC REVIEW (K113337)MeVis Medical Solutions AG2011-12-30
VANTAGE TITAN HSR (K112003)Toshibamedical Systems Corporation2011-12-02
MAGNETOM AERA AND MAGNETOM SKYRA (K111242)Siemens Medical Solutions USA, Inc.2011-11-23
DISCOVERY MR750W 3.0T (K103327)Ge Healthcare Japan Corporation2011-09-30
VANTAGE TITAN 3T (K102489)Toshiba Medical Systems Corporation, Japan2011-08-02
PICA WHOLE-BODY MRI SYSTEM (K110942)Time Medical Limited2011-07-26
G-SCAN (K111803)Esaote, S.p.A.2011-07-15
ENDOSCOUT TRACKING SYSTEM (K111226)Robin Medical, Inc.2011-07-01
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM (K111340)Medtec, Inc.2011-06-28
A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 (K110802)Esaote, S.p.A.2011-04-08
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151)Philips Health Care2011-03-22
IDEAL IQ SOFTWARE OPTION (K103411)GE Medical Systems2011-03-22
G-SCAN (K110238)Esaote, S.p.A.2011-02-17
1.5T OPTIMA MR430S (K103238)Ge Medical Systems, LLC2011-02-11
BRIVO MR355, OPTIMA MR360 (K103330)Ge Hangwei Medical Systems Co., Ltd.2011-02-11
MEDICAL VISORS MV100 (K103507)Medical Visors, Inc.2011-02-08
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS (K102344)Philips Medical Systems Nederland B.V.2010-11-09
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO (K101813)Imris, Inc.2010-10-05
MAGNETOM AERA; MAGNETOM SKYRA (K101347)Siemens Medical Solutions USA, Inc.2010-10-01
MR RADIATION ONCOLOGY OPTIONS (K102155)Ge Medical Systems, LLC2010-08-31
MROPEN (K101295)Paramed S.R.L.2010-07-28
MRI PATIENT POSITIONING DEVICES (K093738)Medtec, Inc.2010-05-14
MR INSPIRE WITH EXTENDED KIT (K100164)Paramed S.R.L.2010-04-05
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 (K093984)Time Medical Limited2010-03-24
POLESTAR, MODEL N-30 (K092308)Medtronic Navigation Israel, Ltd.2010-03-16
DIAGNOSOFT HARP MODEL 2.06 (K100352)Diagnosoft, Inc.2010-03-11
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM (K093336)Medical Numerics, Inc.2010-03-05
3D ASL (K092925)Ge Medical Systems, LLC2010-01-06
O-SCAN MR SYSTEM (K092469)Esaote, S.p.A.2009-12-23
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 (K092230)Time Medical Limited2009-11-25
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 (K092899)Ningbo Xingaoyi Magnetism Co., Ltd.2009-11-10
MODIFICATION TO FMRI HARDWARE SYSTEM (K092253)Nordicneurolab2009-10-08
NSM-S15 SYSTEM (K092237)Neusoft Medical Systems Co., Ltd.2009-09-09
IMRX (K091166)Imris, Inc.2009-09-02
PICA WHOLE BODY MRI SYSTEM (K091580)Time Medical Limited2009-07-24
MR-TOUCH OPTION (K083421)Ge Medical Systems, LLC2009-07-24
PERFSCAPE (K091444)Olea Medical2009-07-20
OPTIMA MR450W (K091536)Ge Medical Systems, LLC2009-07-17
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III (K091669)Xioao Mdt Technology Co, Ltd.2009-06-18
SYNGO BREVIS (K090038)Siemens Medical Solutions USA, Inc.2009-04-28
I OPEN 0.5T (K090873)Beijing Wandong Medical Equipment Co., Ltd.2009-04-10
I_OPEN 0.4T (K090433)Beijing Wandong Medical Equipment Co., Ltd.2009-03-25
CIRRUS OPEN (K090080)Mri-Tech Sp. Zo.O.2009-03-23
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) (K082964)Prism Clinical Imaging, Inc.2009-03-09
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