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 |
|---|---|---|---|
| Dec 19, 2017 | K173600 | MAGNETOM Amira Siemens Medical Solutions USA, Inc. | LNH |
| Nov 21, 2017 | K172685 | LiverMultiScan Perspectum Diagnostics, Ltd., GB | LNH |
| Nov 17, 2017 | K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GX Toshiba Medical Systems Corporation, Japan, JP | LNH |
| Oct 12, 2017 | K170840 | MAGNETOM Terra Siemens Medical Solutions USA, Inc. | LNH |
| Aug 29, 2017 | K162943 | SyMRI Syntheticmr AB, SE | LNH |
| Jul 21, 2017 | K171597 | Vantage Elan 1.5T, V4.0 Toshibamedical Systems Corporation, JP | LNH |
| Jul 19, 2017 | K170978 | Embrace Neonatal MRI System Aspect Imaging, Ltd., IL | LNH |
| Jul 14, 2017 | K171128 | SIGNA Premier Ge Medical Systems, LLC | LNH |
| Jul 14, 2017 | K170090 | RTHawk, HeartVista Cardiac Package Heartvista, Inc. | LNH |
| Jun 14, 2017 | K170396 | MAGNETOM Vida Siemens Medical Solutions USA, Inc. | LNH |
| Jun 7, 2017 | K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX Toshibamedical Systems Corporation, JP | LNH |
| Apr 20, 2017 | K162722 | HyperSense Ge Medical Systems, LLC | LNH |
| Apr 10, 2017 | K163192 | Comfort EC710 Alltech Medical Systems America, Inc. | LNH |
| Mar 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artis Ge Medical Systems, LLC | LNH |
| Jan 27, 2017 | K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Siemens Medical Solutions USA, Inc. | LNH |
| Jan 27, 2017 | K163211 | MAGNETOM Sempra with syngo MR E11S Siemens Medical Solutions USA, Inc. | LNH |
| Jan 6, 2017 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland B.V., NL | LNH |
| Jan 6, 2017 | K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 Philips Medical Systems Nederland B.V., NL | LNH |
| Dec 30, 2016 | K162940 | MultiBand SENSE Philips Medical Systems Nederland B.V., NL | LNH |
| Nov 25, 2016 | K162183 | Vantage Galan 3T, MRT-3020, V4.0 Toshibamedical Systems Corporation, JP | LNH |
| Nov 22, 2016 | K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit Siemens Medi Cal Solutions, Inc. | LNH |
| Nov 18, 2016 | K162403 | HyperBand Ge Medical Systems, LLC | LNH |
| Nov 18, 2016 | K161795 | MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. | LNH |
| Oct 25, 2016 | K161973 | G-scan Brio, S-scan Esaote, S.p.A., IT | LNH |
| Sep 1, 2016 | K161567 | SIGNA Voyager GE Healthcare | LNH |
| Aug 31, 2016 | K161397 | MAGiC Ge Medical Systems, LLC | LNH |
| Aug 23, 2016 | K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software Toshibamedical Systems Corporation, JP | LNH |
| Jul 8, 2016 | K161238 | S-scan Esaote, S.p.A., IT | LNH |
| Jun 30, 2016 | K153740 | RTHawk, HeartVista Cardiac Package Heartvista, Inc. | LNH |
| Jun 9, 2016 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC | LNH |
| May 20, 2016 | K160152 | Trillium Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Apr 15, 2016 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit Siemens Medi Cal Solutions, Inc. | LNH |
| Mar 31, 2016 | K153547 | ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Mar 31, 2016 | K153447 | MAGNETOM Spectra Siemens Medical Solutions USA, Inc. | LNH |
| Mar 29, 2016 | K160621 | SIGNAPioneer GE Healthcare | LNH |
| Mar 22, 2016 | K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 Philips Medical Systems Nederlands B.V., NL | LNH |
| Mar 1, 2016 | K160185 | Wrist 3 Aspect Imaging, Ltd., IL | LNH |
| Jan 8, 2016 | K153039 | MRI Dynamic Analysis Plus Esaote, S.p.A., IT | LNH |
| Dec 24, 2015 | K152283 | MAGNETOM Amira Siemens Medical Solutions USA, Inc. | LNH |
| Dec 22, 2015 | K151074 | Magnetic Reasonance Imaging System Jiangsu Magspin Instrument Co.,Ltd, CN | LNH |
| Oct 27, 2015 | K153003 | SIGNA Pioneer GE Healthcare | LNH |
| Oct 23, 2015 | K152371 | Vantage Titan 3T Toshibamedical Systems Corporation, JP | LNH |
| Oct 15, 2015 | K151466 | MrOpen Paramed S.R.L., IT | LNH |
| Sep 29, 2015 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit Siemens Medical Solutions USA, Inc. | LNH |
| Sep 8, 2015 | K151668 | S-scan Esaote, S.p.A., IT | LNH |
| Jul 29, 2015 | K151015 | ECHELON Oval V 5.0 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Jul 10, 2015 | K143345 | SIGNA Pioneer Ge Healthcare Japan Corporation, JP | LNH |
| Jun 23, 2015 | K143020 | LiverMultiScan Mirada Medical, Ltd., GB | LNH |
| May 8, 2015 | K143606 | MultiBand SENSE Philips Medical Systems Nethrlands BV, NL | LNH |
| Apr 17, 2015 | K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 Toshibamedical Systems Corporation, JP | LNH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.