System, Nuclear Magnetic Resonance Imaging
Regulation 892.1000
28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
Top companies in LNH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2009 | K083421 | MR-TOUCH OPTION Ge Medical Systems, LLC | LNH |
| Jul 20, 2009 | K091444 | PERFSCAPE Olea Medical | LNH |
| Jul 17, 2009 | K091536 | OPTIMA MR450W Ge Medical Systems, LLC | LNH |
| Jun 18, 2009 | K091669 | OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III Xioao Mdt Technology Co, Ltd. | LNH |
| Apr 28, 2009 | K090038 | SYNGO BREVIS Siemens Medical Solutions USA, Inc. | LNH |
| Apr 10, 2009 | K090873 | I OPEN 0.5T Beijing Wandong Medical Equipment Co., Ltd., CN | LNH |
| Mar 25, 2009 | K090433 | I_OPEN 0.4T Beijing Wandong Medical Equipment Co., Ltd., CN | LNH |
| Mar 23, 2009 | K090080 | CIRRUS OPEN Mri-Tech Sp. Zo.O., CA | LNH |
| Mar 9, 2009 | K082964 | PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) Prism Clinical Imaging, Inc. | LNH |
| Feb 17, 2009 | K083533 | ECHELON C MRI SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Dec 16, 2008 | K083137 | NEURO III-SV Imris, Inc. | LNH |
| Nov 7, 2008 | K082427 | SYNGO MR B17 Siemens Medical Solutions USA, Inc. | LNH |
| Nov 4, 2008 | K083147 | DISCOVERY MR450 Ge Medical Systems, LLC | LNH |
| Oct 1, 2008 | K082331 | MAGNETOM C! Siemens Medical Solutions USA, Inc. | LNH |
| Sep 16, 2008 | K073425 | MODIFICATION TO AURORA MRI SYSTEM Aurora Imaging Technology, Inc. | LNH |
| Sep 9, 2008 | K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A Neusoft Medical Systems Co., Ltd., CN | LNH |
| Aug 6, 2008 | K082100 | ALLTECH ECHOSTAR 1.5 T MR SYSTEM Alltech Medical Systems America, Inc. | LNH |
| Jul 22, 2008 | K081916 | GE SIGNA MR ONCOLOGY PACKAGE Ge Medical Systems, LLC | LNH |
| May 23, 2008 | K073362 | MROPEN Paramed S.R.L. | LNH |
| May 16, 2008 | K080515 | FMRI HARDWARE SYSTEM Nordicneurolab, NO | LNH |
| May 15, 2008 | K080762 | IB NEURO, VERSION 1.0 Imaging Biometrics, LLC | LNH |
| Apr 29, 2008 | K080968 | S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA Esaote, S.p.A. | LNH |
| Apr 25, 2008 | K081028 | SIGNA 3.0T MR750 SYSTEM Ge Medical Systems, LLC | LNH |
| Mar 10, 2008 | K080098 | MRJ EXTENDED Paramed S.R.L. | LNH |
| Mar 4, 2008 | K073156 | QPLAQUE MR Medis Medical Imaging Systems BV, NL | LNH |
| Feb 6, 2008 | K080048 | MSK EXTREME MR SCANNER, MODEL AA5000 Oni Medical Systems, Inc. | LNH |
| Feb 1, 2008 | K073457 | MSTAR MPD4500 Xinaomdt Technology Co., Ltd., CN | LNH |
| Jan 22, 2008 | K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 Toshiba America Medical Systems, In.C | LNH |
| Jan 4, 2008 | K073167 | BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER Ge Medical Systems, LLC | LNH |
| Dec 10, 2007 | K072473 | CHASE MR SYSTEM Chase Medical, LP | LNH |
| Nov 21, 2007 | K073081 | JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X Toshiba America Medical Systems, In.C | LNH |
| Nov 21, 2007 | K072850 | MRI SYSTEM, MODEL MAGFINDER II / AI 3200 Advanced Imaging Laboratory | LNH |
| Nov 20, 2007 | K073099 | FMRI HARDWARE SYSTEM Nordicneurolab | LNH |
| Nov 15, 2007 | K070968 | CHOY COMPRESSION FRAME Choy Medical Technologies, Inc. | LNH |
| Nov 1, 2007 | K072998 | IDEAL SOFTWARE OPTION FOR GE MR SCANNERS Ge Medical Systems, LLC | LNH |
| Oct 10, 2007 | K072237 | MAGNETOM VERIO Siemens Medical Solutions USA, Inc. | LNH |
| Sep 21, 2007 | K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. | LNH |
| Aug 14, 2007 | K071925 | MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. | LNH |
| May 22, 2007 | K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB Imris, Inc. | LNH |
| May 10, 2007 | K071154 | SUPERSTAR 0.35T MRI SYSTEM Neusoft Medical Systems Co., Ltd., CN | LNH |
| Jan 4, 2007 | K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 Philips Medical Systems | LNH |
| Nov 21, 2006 | K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 Toshiba America Medical Systems, In.C | LNH |
| Nov 9, 2006 | K063207 | S-SCAN MRI SYSTEM Esaote, S.p.A. | LNH |
| Nov 3, 2006 | K062454 | MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES Siemens Medi Cal Solutions, Inc. | LNH |
| Oct 27, 2006 | K062860 | MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A Neusoft Medical Systems Co., Ltd., CN | LNH |
| Aug 11, 2006 | K061916 | NEURO II-SE, MODELS OR-MB-DR AND OR-DR Imris, Inc. | LNH |
| Jul 28, 2006 | K061930 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY Fonar Corp. | LNH |
| Jul 28, 2006 | K061368 | DIAGNOSOFT HARP Diagnosoft, Inc. | LNH |
| Jul 25, 2006 | K061429 | DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA Esaote, S.p.A. | LNH |
| Jun 13, 2006 | K061255 | BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 Kyron Clinical Imaging, Inc. | LNH |
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