FDA Product Code
FDA Product Code LNH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 1,108 records · page 3 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019-07-01 | Traditional | PDF ↗ |
| K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics, Ltd. | 2019-06-27 | Traditional | PDF ↗ |
| K191128 | Vantage Titan 3T, MRT-3010, V2.5 | Canon Medical Systems Corporation | 2019-06-26 | Traditional | PDF ↗ |
| K191036 | SyMRI | Syntheticmr AB | 2019-06-13 | Traditional | PDF ↗ |
| K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | Philips Medical Systems Nederland B.V. | 2019-06-04 | Abbreviated | PDF ↗ |
| K190757 | MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. | 2019-05-31 | Traditional | PDF ↗ |
| K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-05-29 | Special | PDF ↗ |
| K183657 | Vantage Galan 3T, MRT-3020/A9, V5.0 | Canon Medical Systems Corporation | 2019-03-15 | Traditional | PDF ↗ |
| K183621 | EMMA 1.5T MRI System | Time Medical Limited | 2019-02-22 | Abbreviated | PDF ↗ |
| K183222 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | 2019-02-15 | Traditional | PDF ↗ |
| K190138 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | 2019-02-15 | Special | PDF ↗ |
| K182756 | MyoStrain 5.1 | Myocardial Solutions | 2019-02-14 | Traditional | PDF ↗ |
| K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | 2019-02-14 | Abbreviated | PDF ↗ |
| K183221 | MAGNETOM Amira, MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | 2019-02-14 | Traditional | PDF ↗ |
| K183244 | MAGNETOM Lumina | Siemens Medical Solutions USA, Inc. | 2019-01-24 | Traditional | PDF ↗ |
| K183685 | O-Scan | Esaote, S.p.A. | 2019-01-22 | Special | PDF ↗ |
| K183231 | SIGNA Premier | Ge Medical Systems, LLC | 2019-01-18 | Traditional | PDF ↗ |
| K183254 | Magnetom Vida | Siemens Medical Solutions USA, Inc. | 2019-01-18 | Traditional | PDF ↗ |
| K183137 | uMR 580, uMR 588 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-01-11 | Traditional | PDF ↗ |
| K173749 | AMRA Profiler | Amra Medical AB | 2018-12-06 | Traditional | PDF ↗ |
| K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | Siemens Medical Solutions USA, Inc. | 2018-11-06 | Traditional | PDF ↗ |
| K182299 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | 2018-10-26 | Traditional | PDF ↗ |
| K181433 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2018-10-19 | Traditional | PDF ↗ |
| K182282 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | 2018-10-19 | Traditional | PDF ↗ |
| K182129 | MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | 2018-10-12 | Traditional | PDF ↗ |
| K181322 | MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | 2018-10-05 | Traditional | PDF ↗ |
| K181371 | uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 | Traditional | PDF ↗ |
| K181370 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 | Traditional | PDF ↗ |
| K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation | 2018-08-13 | Traditional | PDF ↗ |
| K181479 | Ingenia Ambition S and Ingenia Ambition X | Philips Medical Systems Nederland B.V. | 2018-08-03 | Abbreviated | PDF ↗ |
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Philips Healthcare (Suzhou) Co., Ltd. | 2018-06-15 | Abbreviated | PDF ↗ |
| K180100 | MRIaudio PREM System | Mriaudio | 2018-06-14 | Traditional | PDF ↗ |
| K181093 | SyMRI | Syntheticmr AB | 2018-06-12 | Traditional | PDF ↗ |
| K180926 | uMR 560 | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 | Traditional | PDF ↗ |
| K180925 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 | Traditional | PDF ↗ |
| K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | Philips Medical Systems Nederland B.V. | 2018-04-04 | Abbreviated | PDF ↗ |
| K180592 | G-scan Brio | Esaote, S.p.A. | 2018-03-30 | Special | PDF ↗ |
| K173617 | MAGNETOM Vida with Compressed Sensing GRASP-VIBE | Siemens Medical Solutions USA, Inc. | 2018-03-30 | Traditional | PDF ↗ |
| K173451 | Ingenia Elition S and Ingenia Elition X | Philips Medical Systems Nederland B.V. | 2018-03-20 | Abbreviated | PDF ↗ |
| K171778 | MR Wireless Gating System, Model WGS-100 | Ivy Biomedical Systems, Inc. | 2018-03-14 | Traditional | PDF ↗ |
| K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | Philips Medical Systems Nederland B.V. | 2018-03-06 | Abbreviated | PDF ↗ |
| K173224 | SPIN-SWI | Spintech, Inc. | 2018-02-23 | Traditional | PDF ↗ |
| K173409 | Wireless Audio System | Neocoil, LLC | 2018-02-16 | Traditional | PDF ↗ |
| K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | Siemens Medical Solutions USA, Inc. | 2018-02-13 | Traditional | PDF ↗ |
| K173558 | SyMRI | Syntheticmr AB | 2018-01-26 | Traditional | PDF ↗ |
| K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | 2018-01-26 | Traditional | PDF ↗ |
| K172920 | 3D APT | Philips Medical Systems Nederland B.V. | 2018-01-22 | Abbreviated | PDF ↗ |
| K172110 | ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation | 2018-01-11 | Traditional | PDF ↗ |
| K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017-12-19 | Special | PDF ↗ |
| K172685 | LiverMultiScan | Perspectum Diagnostics, Ltd. | 2017-11-21 | Traditional | PDF ↗ |
| K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GX | Toshiba Medical Systems Corporation, Japan | 2017-11-17 | Traditional | PDF ↗ |
| K170840 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | 2017-10-12 | Traditional | PDF ↗ |
| K162943 | SyMRI | Syntheticmr AB | 2017-08-29 | Traditional | PDF ↗ |
| K171597 | Vantage Elan 1.5T, V4.0 | Toshibamedical Systems Corporation | 2017-07-21 | Traditional | PDF ↗ |
| K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2017-07-19 | Traditional | PDF ↗ |
| K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2017-07-14 | Special | PDF ↗ |
| K171128 | SIGNA Premier | Ge Medical Systems, LLC | 2017-07-14 | Traditional | PDF ↗ |
| K170396 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2017-06-14 | Traditional | PDF ↗ |
| K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | 2017-06-07 | Traditional | PDF ↗ |
| K162722 | HyperSense | Ge Medical Systems, LLC | 2017-04-20 | Traditional | PDF ↗ |
| K163192 | Comfort EC710 | Alltech Medical Systems America, Inc. | 2017-04-10 | Traditional | PDF ↗ |
| K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | Ge Medical Systems, LLC | 2017-03-17 | Traditional | PDF ↗ |
| K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | Siemens Medical Solutions USA, Inc. | 2017-01-27 | Traditional | PDF ↗ |
| K163211 | MAGNETOM Sempra with syngo MR E11S | Siemens Medical Solutions USA, Inc. | 2017-01-27 | Traditional | PDF ↗ |
| K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | Philips Medical Systems Nederland B.V. | 2017-01-06 | Abbreviated | PDF ↗ |
| K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | Philips Medical Systems Nederland B.V. | 2017-01-06 | Abbreviated | PDF ↗ |
| K162940 | MultiBand SENSE | Philips Medical Systems Nederland B.V. | 2016-12-30 | Traditional | PDF ↗ |
| K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Toshibamedical Systems Corporation | 2016-11-25 | Traditional | PDF ↗ |
| K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | Siemens Medi Cal Solutions, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K161795 | MAGNETOM ESSENZA | Siemens Medical Solutions USA, Inc. | 2016-11-18 | Special | PDF ↗ |
| K162403 | HyperBand | Ge Medical Systems, LLC | 2016-11-18 | Traditional | PDF ↗ |
| K161973 | G-scan Brio, S-scan | Esaote, S.p.A. | 2016-10-25 | Traditional | PDF ↗ |
| K161567 | SIGNA Voyager | GE Healthcare | 2016-09-01 | Traditional | PDF ↗ |
| K161397 | MAGiC | Ge Medical Systems, LLC | 2016-08-31 | Traditional | PDF ↗ |
| K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Toshibamedical Systems Corporation | 2016-08-23 | Traditional | PDF ↗ |
| K161238 | S-scan | Esaote, S.p.A. | 2016-07-08 | Special | PDF ↗ |
| K153740 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2016-06-30 | Traditional | PDF ↗ |
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | Ge Medical Systems, LLC | 2016-06-09 | Special | PDF ↗ |
| K160152 | Trillium Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016-05-20 | Traditional | PDF ↗ |
| K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K153547 | ECHELON Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016-03-31 | Special | PDF ↗ |
| K153447 | MAGNETOM Spectra | Siemens Medical Solutions USA, Inc. | 2016-03-31 | Special | PDF ↗ |
| K160621 | SIGNAPioneer | GE Healthcare | 2016-03-29 | Special | PDF ↗ |
| K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | Philips Medical Systems Nederlands B.V. | 2016-03-22 | Abbreviated | PDF ↗ |
| K160185 | Wrist 3 | Aspect Imaging, Ltd. | 2016-03-01 | Traditional | PDF ↗ |
| K153039 | MRI Dynamic Analysis Plus | Esaote, S.p.A. | 2016-01-08 | Special | PDF ↗ |
| K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015-12-24 | Traditional | PDF ↗ |
| K151074 | Magnetic Reasonance Imaging System | Jiangsu Magspin Instrument Co.,Ltd | 2015-12-22 | Traditional | PDF ↗ |
| K153003 | SIGNA Pioneer | GE Healthcare | 2015-10-27 | Special | PDF ↗ |
| K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015-10-23 | Traditional | PDF ↗ |
| K151466 | MrOpen | Paramed S.R.L. | 2015-10-15 | Traditional | PDF ↗ |
| K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | 2015-09-29 | Traditional | PDF ↗ |
| K151668 | S-scan | Esaote, S.p.A. | 2015-09-08 | Traditional | PDF ↗ |
| K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015-07-29 | Traditional | PDF ↗ |
| K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | 2015-07-10 | Traditional | PDF ↗ |
| K143020 | LiverMultiScan | Mirada Medical, Ltd. | 2015-06-23 | Traditional | PDF ↗ |
| K143606 | MultiBand SENSE | Philips Medical Systems Nethrlands BV | 2015-05-08 | Traditional | PDF ↗ |
| K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | 2015-04-17 | Traditional | PDF ↗ |
| K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015-04-09 | Traditional | PDF ↗ |
| K142421 | G-scan Brio | Esaote, S.p.A. | 2015-04-09 | Traditional | PDF ↗ |
Product code LNH · Class II · Radiology. Data: openFDA.