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LNH

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

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RecordFirmDate
ECHELON C MRI SYSTEM (K083533)Hitachi Medical Systems America, Inc.2009-02-17
NEURO III-SV (K083137)Imris, Inc.2008-12-16
SYNGO MR B17 (K082427)Siemens Medical Solutions USA, Inc.2008-11-07
DISCOVERY MR450 (K083147)Ge Medical Systems, LLC2008-11-04
MAGNETOM C! (K082331)Siemens Medical Solutions USA, Inc.2008-10-01
MODIFICATION TO AURORA MRI SYSTEM (K073425)Aurora Imaging Technology, Inc.2008-09-16
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A (K082485)Neusoft Medical Systems Co., Ltd.2008-09-09
ALLTECH ECHOSTAR 1.5 T MR SYSTEM (K082100)Alltech Medical Systems America, Inc.2008-08-06
GE SIGNA MR ONCOLOGY PACKAGE (K081916)Ge Medical Systems, LLC2008-07-22
MROPEN (K073362)Paramed S.R.L.2008-05-23
FMRI HARDWARE SYSTEM (K080515)Nordicneurolab2008-05-16
IB NEURO, VERSION 1.0 (K080762)Imaging Biometrics, LLC2008-05-15
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA (K080968)Esaote, S.p.A.2008-04-29
SIGNA 3.0T MR750 SYSTEM (K081028)Ge Medical Systems, LLC2008-04-25
MRJ EXTENDED (K080098)Paramed S.R.L.2008-03-10
QPLAQUE MR (K073156)Medis Medical Imaging Systems BV2008-03-04
MSK EXTREME MR SCANNER, MODEL AA5000 (K080048)Oni Medical Systems, Inc.2008-02-06
MSTAR MPD4500 (K073457)Xinaomdt Technology Co., Ltd.2008-02-01
VANTAGE TITAN, MODEL MRT-1504/S3 (K080038)Toshiba America Medical Systems, In.C2008-01-22
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER (K073167)Ge Medical Systems, LLC2008-01-04
CHASE MR SYSTEM (K072473)Chase Medical, LP2007-12-10
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X (K073081)Toshiba America Medical Systems, In.C2007-11-21
MRI SYSTEM, MODEL MAGFINDER II / AI 3200 (K072850)Advanced Imaging Laboratory2007-11-21
FMRI HARDWARE SYSTEM (K073099)Nordicneurolab2007-11-20
CHOY COMPRESSION FRAME (K070968)Choy Medical Technologies, Inc.2007-11-15
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS (K072998)Ge Medical Systems, LLC2007-11-01
MAGNETOM VERIO (K072237)Siemens Medical Solutions USA, Inc.2007-10-10
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K072279)Hitachi Medical Systems America, Inc.2007-09-21
MAGNETOM ESSENZA (K071925)Siemens Medical Solutions USA, Inc.2007-08-14
NEURO II-SE, MODELS: OR-DR-OR, OR-MB (K071099)Imris, Inc.2007-05-22
SUPERSTAR 0.35T MRI SYSTEM (K071154)Neusoft Medical Systems Co., Ltd.2007-05-10
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 (K063559)Philips Medical Systems2007-01-04
EXCELART VANTAGE ATLAS, MODEL MRT-1503 (K063361)Toshiba America Medical Systems, In.C2006-11-21
S-SCAN MRI SYSTEM (K063207)Esaote, S.p.A.2006-11-09
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES (K062454)Siemens Medi Cal Solutions, Inc.2006-11-03
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A (K062860)Neusoft Medical Systems Co., Ltd.2006-10-27
NEURO II-SE, MODELS OR-MB-DR AND OR-DR (K061916)Imris, Inc.2006-08-11
DIAGNOSOFT HARP (K061368)Diagnosoft, Inc.2006-07-28
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY (K061930)Fonar Corp.2006-07-28
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA (K061429)Esaote, S.p.A.2006-07-25
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 (K061255)Kyron Clinical Imaging, Inc.2006-06-13
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 (K061132)Neusoft Medical Systems Co., Ltd.2006-05-24
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 (K060956)Esaote, S.p.A.2006-05-04
ALTAIRE INTERVENTIONAL MR PACKAGE (K053309)Hitachi Medical Systems America, Inc.2006-01-24
EXCELART VANTAGE ZGV (K060003)Toshibamedical Systems Corporation2006-01-18
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION (K052423)Siemens Medi Cal Solutions, Inc.2006-01-13
CADIMAS VERSION 1.0 (K052023)Alan Penn & Associates., Inc.2005-12-08
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K053009)GE Medical Systems2005-11-17
GE 1.5T SIGNA HDE MR SYSTEM (K052978)Ge Medical Systems, LLC2005-11-09
MODIFICATION TO: AURORA (K052698)Aurora Imaging Technology, Inc.2005-11-08
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC (K052987)Noras Rontgen-Und Medizintechnik GmbH2005-11-08
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 (K052571)Neurognostics, Inc.2005-10-17
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A (K052164)Siemens Medical Solutions USA, Inc.2005-10-04
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM (K052172)Hitachi Medical Systems America, Inc.2005-09-27
PORTAL GRAVITY SYSTEM (K052579)Portal, Inc.2005-09-27
SIMTEC IM-MAXX 2 OPTION (K052315)Siemens Medical Solutions USA, Inc.2005-09-22
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293)Ge Medical Systems, LLC2005-09-21
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A (K052305)Siemens Medical Solutions USA, Inc.2005-09-08
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES (K052078)Philips Medical Systems Nederland B.V.2005-09-07
ACHIEVA 1.5T & INERA 1.5T FAMILY (K052013)Philips Medical Systems Nederland B.V.2005-08-02
ALTAIRE (K050602)Hitachi Medical Systems America, Inc.2005-04-07
STARSHIELD V3 RF TRNT (K050237)Odin Medical Technologies , Ltd.2005-03-18
MAGNETOM TRIO A TIM SYSTEM (K050200)Siemens Medical Solutions USA, Inc.2005-02-28
MAGNETOM SYMPHONY A TIM SYSTEM (K050199)Siemens Medical Solution2005-02-18
NEURO II-S (K050132)Innovative Magnetic Resonance Imaging Systems, Inc.2005-02-15
ACHIEVA FAMILY (K043147)Philips Medical Systems North America Co.2005-02-15
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0 (K043290)Neurognostics, Inc.2005-01-28
R2-MRI ANALYSIS SYSTEM (K043271)Inner Vision Biometrics Pty, Ltd.2005-01-21
GE SIGNA EXCITE MR SURGICAL OPTION (K043262)GE Healthcare2005-01-12
MAGNETOM C! MR SYSTEM (K043030)Siemens Medical Solutions2004-12-09
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM (K043112)General Electric Co.2004-11-24
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM (K042948)Wandong Medical2004-11-03
G-SCAN (K042236)Esaote, S.p.A.2004-10-04
PANORAMA 1.0T (K041602)Philips Medical Systems North America, Inc.2004-07-26
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K041695)Usa Instruments, Inc.2004-07-23
DYNACAD V1.0 (K041286)Mri Devices Corp.2004-07-21
MAGNETOM ESPREE SYSTEM (K041112)Siemens Medical Solutions USA, Inc.2004-07-21
MAGNETOM C! MR SYSTEM (K041111)Siemens Medical Solutions USA, Inc.2004-07-16
CADSTREAM VERSION 3.1 (K041020)Confirma, Inc.2004-07-07
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577)Adac Laboratories2004-06-25
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476)Ge Medical Systems, LLC2004-06-17
ARTOSCAN C (K040877)Esaote, S.p.A.2004-05-04
ENDOSCOUT (K033485)Robin Medical, Inc.2004-04-20
GE SIGNA 3.0T WITH EXCITE MR SYSTEM (K040444)General Electric Co.2004-04-14
MRJ (K033507)Paramed S.R.L.2004-01-20
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS (K033867)General Electric Co.2003-12-19
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K033504)General Electric Co.2003-11-25
SUPEROPEN 0.23T, MODEL NAM-P023A (K033315)Neusoft Digital Medical Systems Co., Ltd.2003-10-29
MAGNETOM AVANTO MR SYSTEM (K032428)Siemens Medical Solutions USA, Inc.2003-10-16
GE 0.2T SIGNA PROFILE/I MR SYSTEM (K033168)General Electric Co.2003-10-10
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM (K032795)Ge Medical Systems, LLC2003-10-08
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE (K032232)Hitachi Medical Systems America, Inc.2003-09-29
MODIFICATION TO: AURORA (K032678)Aurora Imaging Technology, Inc.2003-09-24
POLESTAR N-20 (K032541)Odin Medical Technologies , Ltd.2003-09-12
INTERA-SENSATION FAMILY (K031815)Philips Medical Systems2003-09-10
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 (K032490)Toshiba America Medical Systems, In.C2003-08-21
MODIFICATION TO E-SCAN XQ (K032121)Esaote, S.p.A.2003-08-13
MR FIBER OPTIC ECG GATING SYSTEM (K031731)Sa Instruments, Inc.2003-07-30
AURORA (K032082)Aurora Imaging Technology, Inc.2003-07-30
GE DELTA SOFTWARE OPTION FOR MRI (K031927)GE Medical Systems2003-07-02
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