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 |
|---|---|---|---|
| Aug 10, 2012 | K121997 | IMRIS ONCOLOGY PACKAGE Imris, Inc., CA | LNH |
| Aug 6, 2012 | K122006 | G-SCAN BRIO Esaote, S.p.A. | LNH |
| Jul 16, 2012 | K121160 | MAGNETOM SPECTRA Siemens Medical Solutions USA, Inc. | LNH |
| Jul 9, 2012 | K121650 | S-SCAN Esaote, S.p.A. | LNH |
| Jun 8, 2012 | K121545 | BELLYBOARD, SBRT ACCESSORIES Medtec Inc. Dba Civco Medical Solutions | LNH |
| Jun 1, 2012 | K120638 | VANTAGE TITAN Toshibamedical Systems Corporation | LNH |
| May 24, 2012 | K121239 | MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE Optoacoustics, Ltd. | LNH |
| May 23, 2012 | K120487 | VANTAGE TITAN 3T Toshibamedical Systems Corporation | LNH |
| May 17, 2012 | K113281 | MRI SYTEMS Shenzhen Anke High-Tech Co., Ltd., CN | LNH |
| May 2, 2012 | K113511 | ECHOSTAR SPICA 1.5T MR SYSTEM Alltech Medical Systems America, Inc. | LNH |
| May 1, 2012 | K120748 | SPEEDUP SOFTWARE OPTION Esaote, S.p.A. | LNH |
| May 1, 2012 | K113145 | ECHELON OVAL MRI SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Mar 27, 2012 | K120778 | BRIVO MR355 Ge Hangwei Medical Systems Co., Ltd., CN | LNH |
| Jan 13, 2012 | K113490 | OPTIMA MR450W Ge Medical Systems, LLC | LNH |
| Jan 13, 2012 | K113093 | VANTAGE TITAN 3T Toshibamedical Systems Corporation | LNH |
| Dec 30, 2011 | K113337 | VISIA DYNAMIC REVIEW MeVis Medical Solutions AG | LNH |
| Dec 2, 2011 | K112003 | VANTAGE TITAN HSR Toshibamedical Systems Corporation | LNH |
| Nov 23, 2011 | K111242 | MAGNETOM AERA AND MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. | LNH |
| Sep 30, 2011 | K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, JP | LNH |
| Aug 2, 2011 | K102489 | VANTAGE TITAN 3T Toshiba Medical Systems Corporation, Japan | LNH |
| Jul 26, 2011 | K110942 | PICA WHOLE-BODY MRI SYSTEM Time Medical Limited, CN | LNH |
| Jul 15, 2011 | K111803 | G-SCAN Esaote, S.p.A. | LNH |
| Jul 1, 2011 | K111226 | ENDOSCOUT TRACKING SYSTEM Robin Medical, Inc. | LNH |
| Jun 28, 2011 | K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM Medtec, Inc. | LNH |
| Apr 8, 2011 | K110802 | A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 Esaote, S.p.A. | LNH |
| Mar 22, 2011 | K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T Philips Health Care | LNH |
| Mar 22, 2011 | K103411 | IDEAL IQ SOFTWARE OPTION GE Medical Systems | LNH |
| Feb 17, 2011 | K110238 | G-SCAN Esaote, S.p.A. | LNH |
| Feb 11, 2011 | K103330 | BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd., CN | LNH |
| Feb 11, 2011 | K103238 | 1.5T OPTIMA MR430S Ge Medical Systems, LLC | LNH |
| Feb 8, 2011 | K103507 | MEDICAL VISORS MV100 Medical Visors, Inc. | LNH |
| Nov 9, 2010 | K102344 | MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS Philips Medical Systems Nederland B.V. | LNH |
| Oct 5, 2010 | K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO Imris, Inc. | LNH |
| Oct 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. | LNH |
| Aug 31, 2010 | K102155 | MR RADIATION ONCOLOGY OPTIONS Ge Medical Systems, LLC | LNH |
| Jul 28, 2010 | K101295 | MROPEN Paramed S.R.L. | LNH |
| May 14, 2010 | K093738 | MRI PATIENT POSITIONING DEVICES Medtec, Inc. | LNH |
| Apr 5, 2010 | K100164 | MR INSPIRE WITH EXTENDED KIT Paramed S.R.L. | LNH |
| Mar 24, 2010 | K093984 | PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 Time Medical Limited, CN | LNH |
| Mar 16, 2010 | K092308 | POLESTAR, MODEL N-30 Medtronic Navigation Israel, Ltd., IL | LNH |
| Mar 11, 2010 | K100352 | DIAGNOSOFT HARP MODEL 2.06 Diagnosoft, Inc. | LNH |
| Mar 5, 2010 | K093336 | INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM Medical Numerics, Inc. | LNH |
| Jan 6, 2010 | K092925 | 3D ASL Ge Medical Systems, LLC | LNH |
| Dec 23, 2009 | K092469 | O-SCAN MR SYSTEM Esaote, S.p.A. | LNH |
| Nov 25, 2009 | K092230 | MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 Time Medical Limited, CN | LNH |
| Nov 10, 2009 | K092899 | OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 Ningbo Xingaoyi Magnetism Co., Ltd., CN | LNH |
| Oct 8, 2009 | K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM Nordicneurolab, NO | LNH |
| Sep 9, 2009 | K092237 | NSM-S15 SYSTEM Neusoft Medical Systems Co., Ltd., CN | LNH |
| Sep 2, 2009 | K091166 | IMRX Imris, Inc. | LNH |
| Jul 24, 2009 | K091580 | PICA WHOLE BODY MRI SYSTEM Time Medical Limited, CN | LNH |
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