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 23, 2019 | K191662 | Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation, JP | LNH |
| Jul 12, 2019 | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow Siemens Medical Solutions USA, Inc. | LNH |
| Jul 1, 2019 | K190524 | MRopen 0.5 T Asg Superconductors S.P.A., IT | LNH |
| Jun 27, 2019 | K190017 | LiverMultiScan (LMSv3) Perspectum Diagnostics, Ltd., GB | LNH |
| Jun 26, 2019 | K191128 | Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation, JP | LNH |
| Jun 13, 2019 | K191036 | SyMRI Syntheticmr AB, SE | LNH |
| Jun 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| May 31, 2019 | K190757 | MAGNETOM Avanto Fit Siemens Medical Solution USA, Inc. | LNH |
| May 29, 2019 | K191157 | uMR 780, uMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Mar 15, 2019 | K183657 | Vantage Galan 3T, MRT-3020/A9, V5.0 Canon Medical Systems Corporation, JP | LNH |
| Feb 22, 2019 | K183621 | EMMA 1.5T MRI System Time Medical Limited, CN | LNH |
| Feb 15, 2019 | K190138 | MAGNETOM Aera Siemens Medical Solutions USA, Inc. | LNH |
| Feb 15, 2019 | K183222 | MAGNETOM Terra Siemens Medical Solutions USA, Inc. | LNH |
| Feb 14, 2019 | K183221 | MAGNETOM Amira, MAGNETOM Sempra Siemens Medical Solutions USA, Inc. | LNH |
| Feb 14, 2019 | K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., NL | LNH |
| Feb 14, 2019 | K182756 | MyoStrain 5.1 Myocardial Solutions | LNH |
| Jan 24, 2019 | K183244 | MAGNETOM Lumina Siemens Medical Solutions USA, Inc. | LNH |
| Jan 22, 2019 | K183685 | O-Scan Esaote, S.p.A., IT | LNH |
| Jan 18, 2019 | K183254 | Magnetom Vida Siemens Medical Solutions USA, Inc. | LNH |
| Jan 18, 2019 | K183231 | SIGNA Premier Ge Medical Systems, LLC | LNH |
| Jan 11, 2019 | K183137 | uMR 580, uMR 588 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Dec 6, 2018 | K173749 | AMRA Profiler Amra Medical AB, SE | LNH |
| Nov 6, 2018 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D Siemens Medical Solutions USA, Inc. | LNH |
| Oct 26, 2018 | K182299 | MAGNETOM Aera Siemens Medical Solutions USA, Inc. | LNH |
| Oct 19, 2018 | K182282 | Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation, JP | LNH |
| Oct 19, 2018 | K181433 | MAGNETOM Vida Siemens Medical Solutions USA, Inc. | LNH |
| Oct 12, 2018 | K182129 | MAGNETOM Sola Siemens Medical Solutions USA, Inc. | LNH |
| Oct 5, 2018 | K181322 | MAGNETOM Sola Siemens Medical Solutions USA, Inc. | LNH |
| Oct 3, 2018 | K181371 | uMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Oct 3, 2018 | K181370 | uMR 780 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Aug 13, 2018 | K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation, JP | LNH |
| Aug 3, 2018 | K181479 | Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V., NL | LNH |
| Jun 15, 2018 | K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Philips Healthcare (Suzhou) Co., Ltd., CN | LNH |
| Jun 14, 2018 | K180100 | MRIaudio PREM System Mriaudio | LNH |
| Jun 12, 2018 | K181093 | SyMRI Syntheticmr AB, SE | LNH |
| Jun 6, 2018 | K180926 | uMR 560 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Jun 6, 2018 | K180925 | uMR 570 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Apr 4, 2018 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 Philips Medical Systems Nederland B.V., NL | LNH |
| Mar 30, 2018 | K180592 | G-scan Brio Esaote, S.p.A., IT | LNH |
| Mar 30, 2018 | K173617 | MAGNETOM Vida with Compressed Sensing GRASP-VIBE Siemens Medical Solutions USA, Inc. | LNH |
| Mar 20, 2018 | K173451 | Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V., NL | LNH |
| Mar 14, 2018 | K171778 | MR Wireless Gating System, Model WGS-100 Ivy Biomedical Systems, Inc. | LNH |
| Mar 6, 2018 | K173356 | Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V., NL | LNH |
| Feb 23, 2018 | K173224 | SPIN-SWI Spintech, Inc. | LNH |
| Feb 16, 2018 | K173409 | Wireless Audio System Neocoil, LLC | LNH |
| Feb 13, 2018 | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Siemens Medical Solutions USA, Inc. | LNH |
| Jan 26, 2018 | K173558 | SyMRI Syntheticmr AB, SE | LNH |
| Jan 26, 2018 | K173382 | Vantage Galan 3T, V4.6 Toshibamedical Systems Corporation, JP | LNH |
| Jan 22, 2018 | K172920 | 3D APT Philips Medical Systems Nederland B.V., NL | LNH |
| Jan 11, 2018 | K172110 | ECHELON OVAL V6.0A MRI System Hitachi Healthcare Americas Corporation | LNH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.