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 |
|---|---|---|---|
| Apr 9, 2015 | K143253 | O-MAR Philips Medical Systems Nederland B.V., NL | LNH |
| Apr 9, 2015 | K143008 | Vantage Titan 3T Toshibamedical Systems Corporation, JP | LNH |
| Apr 9, 2015 | K142421 | G-scan Brio Esaote, S.p.A., IT | LNH |
| Mar 20, 2015 | K143128 | mDIXON XD Philips Medical Systems Nederlands B.V., NL | LNH |
| Mar 2, 2015 | K142734 | TRILLIUM Oval MR System Hitachi Medical Systems America, Inc. | LNH |
| Feb 4, 2015 | K143251 | SIGNA Creator, SIGNA Explorer Ge Healthcare (Ge Medical Systems, LLC) | LNH |
| Feb 3, 2015 | K141945 | ECHOSTAR COMFORT 1.5T MRI Alltech Medical Systems America, Inc. | LNH |
| Dec 17, 2014 | K142997 | RTHawk, HeartVista Workstation with RTHawk Heartvista, Inc. | LNH |
| Dec 5, 2014 | K142361 | Discovery MR750 3.0T Ge Medical Systems, LLC | LNH |
| Nov 19, 2014 | K141977 | MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL Siemens Medical Solutions USA, Inc. | LNH |
| Oct 23, 2014 | K131737 | SUPERNOVA C5 MRI SYSTEM Liaoning Kampo Medical System Co., Ltd., CN | LNH |
| Oct 8, 2014 | K142515 | MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra Siemens Medical Solutions USA, Inc. | LNH |
| Sep 26, 2014 | K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T Ge Medical Systems, LLC | LNH |
| Sep 19, 2014 | K141472 | VANTAGE ELAN Toshiba America Medical Systems, In.C | LNH |
| Aug 7, 2014 | K140956 | LCD MONITOR Nordicneurolab, NO | LNH |
| Jul 24, 2014 | K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE Neocoil, LLC | LNH |
| Jun 25, 2014 | K133848 | RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK Heartvista, Inc. | LNH |
| Jun 13, 2014 | K140666 | MR ELASTOGRAPHY Philips Medical Systems Nederland B.V. | LNH |
| Apr 4, 2014 | K132381 | CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT Clearmri Solutions, Inc. | LNH |
| Mar 20, 2014 | K140253 | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE Siemens Medical Solutions USA, Inc. | LNH |
| Feb 28, 2014 | K131896 | SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM Suzhou Anke Medical System Co., Ltd., CN | LNH |
| Feb 12, 2014 | K133526 | MDIXON-QUANT Philips Medical Systems Nederland B.V. | LNH |
| Feb 10, 2014 | K133692 | IMRI 1.5T AND IMRI 3T S Imris, Inc. | LNH |
| Jan 14, 2014 | K130692 | M2 WRIST 2 MRI SYSTEM Aspect Imaging, Ltd. | LNH |
| Dec 30, 2013 | K133490 | G-SCAN BRIO Esaote, S.p.A. | LNH |
| Dec 13, 2013 | K131996 | S-SCAN Esaote, S.p.A. | LNH |
| Dec 13, 2013 | K122035 | HEPAFAT SCAN Resonance Health Analysis Services Pty, Ltd. | LNH |
| Dec 12, 2013 | K133435 | MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A Siemens Medical Solutions USA, Inc. | LNH |
| Nov 22, 2013 | K132119 | MAGNETOM PRISMA, MAGNETOM PRISMA FIT Siemens Medical Solutions USA, Inc. | LNH |
| Nov 15, 2013 | K132951 | MAGNETOM AERA Siemens Medical Solutions USA, Inc. | LNH |
| Nov 15, 2013 | K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T Ge Healthcare (Ge Medical Systems, LLC) | LNH |
| Nov 1, 2013 | K132831 | QUIET/SILENT SCANNING SUITE Siemens Medical Solutions USA, Inc. | LNH |
| Oct 16, 2013 | K132160 | VANTAGE TITAN 3T Toshibamedical Systems Corporation | LNH |
| Aug 30, 2013 | K131241 | SWIP Philips Medical Systems Nederland B.V. | LNH |
| Jul 19, 2013 | K130658 | ELIXBO PM545 Xbo Medical Systems Co., Ltd., CN | LNH |
| May 23, 2013 | K130115 | DISCOVERY MR750W 3.0T Ge Medical Systems, LLC | LNH |
| May 17, 2013 | K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT Siemens Medical Solutions USA, Inc. | LNH |
| May 17, 2013 | K123510 | MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. | LNH |
| Mar 13, 2013 | K123522 | OPTIMA MR450W Ge Healthcare (Ge Medical Systems, LLC) | LNH |
| Mar 1, 2013 | K130262 | MAGNETOM ESSENZA WITH SYNGO MR D14 Siemens Medical Solutions USA, Inc. | LNH |
| Feb 12, 2013 | K123938 | SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN Siemens Medical Solutions USA, Inc. | LNH |
| Feb 7, 2013 | K120701 | M2 WRIST MRI SYSTEM Aspect Imaging, Ltd., IL | LNH |
| Jan 17, 2013 | K123417 | BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd., CN | LNH |
| Dec 13, 2012 | K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US Toshiba America Medical Systems, In.C | LNH |
| Dec 11, 2012 | K113394 | MAVRIC SL Ge Medical Systems, LLC | LNH |
| Dec 6, 2012 | K122034 | MRJ 3300 Paramed S.R.L., IT | LNH |
| Nov 13, 2012 | K123068 | OPTIMA MR 430S Ge Medical Systems, LLC | LNH |
| Nov 5, 2012 | K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO Siemens Medi Cal Solutions, Inc. | LNH |
| Sep 21, 2012 | K122026 | PRISM ACQUIRE PRISM PROCESS PRISM VIEW Prism Clinical Imaging, Inc. | LNH |
| Sep 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT Ge Medical Systems, LLC | LNH |
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