LNH
1,101 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| Vantage Galan 3T, MRT-3020/A9, V5.0 (K183657) | Canon Medical Systems Corporation | 2019-03-15 |
| EMMA 1.5T MRI System (K183621) | Time Medical Limited | 2019-02-22 |
| MAGNETOM Terra (K183222) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |
| MAGNETOM Aera (K190138) | Siemens Medical Solutions USA, Inc. | 2019-02-15 |
| MAGNETOM Amira, MAGNETOM Sempra (K183221) | Siemens Medical Solutions USA, Inc. | 2019-02-14 |
| MyoStrain 5.1 (K182756) | Myocardial Solutions | 2019-02-14 |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) | Philips Medical Systems Nederland B.V. | 2019-02-14 |
| MAGNETOM Lumina (K183244) | Siemens Medical Solutions USA, Inc. | 2019-01-24 |
| O-Scan (K183685) | Esaote, S.p.A. | 2019-01-22 |
| Magnetom Vida (K183254) | Siemens Medical Solutions USA, Inc. | 2019-01-18 |
| SIGNA Premier (K183231) | Ge Medical Systems, LLC | 2019-01-18 |
| uMR 580, uMR 588 (K183137) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-01-11 |
| AMRA Profiler (K173749) | Amra Medical AB | 2018-12-06 |
| MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D (K181613) | Siemens Medical Solutions USA, Inc. | 2018-11-06 |
| MAGNETOM Aera (K182299) | Siemens Medical Solutions USA, Inc. | 2018-10-26 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K182282) | Canon Medical Systems Corporation | 2018-10-19 |
| MAGNETOM Vida (K181433) | Siemens Medical Solutions USA, Inc. | 2018-10-19 |
| MAGNETOM Sola (K182129) | Siemens Medical Solutions USA, Inc. | 2018-10-12 |
| MAGNETOM Sola (K181322) | Siemens Medical Solutions USA, Inc. | 2018-10-05 |
| uMR 790 (K181371) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| uMR 780 (K181370) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593) | Canon Medical Systems Corporation | 2018-08-13 |
| Ingenia Ambition S and Ingenia Ambition X (K181479) | Philips Medical Systems Nederland B.V. | 2018-08-03 |
| Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 (K173507) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-06-15 |
| MRIaudio PREM System (K180100) | Mriaudio | 2018-06-14 |
| SyMRI (K181093) | Syntheticmr AB | 2018-06-12 |
| uMR 560 (K180926) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| uMR 570 (K180925) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (K173079) | Philips Medical Systems Nederland B.V. | 2018-04-04 |
| MAGNETOM Vida with Compressed Sensing GRASP-VIBE (K173617) | Siemens Medical Solutions USA, Inc. | 2018-03-30 |
| G-scan Brio (K180592) | Esaote, S.p.A. | 2018-03-30 |
| Ingenia Elition S and Ingenia Elition X (K173451) | Philips Medical Systems Nederland B.V. | 2018-03-20 |
| MR Wireless Gating System, Model WGS-100 (K171778) | Ivy Biomedical Systems, Inc. | 2018-03-14 |
| Ingenia Elition S and Ingenia Elition X R5.4 (K173356) | Philips Medical Systems Nederland B.V. | 2018-03-06 |
| SPIN-SWI (K173224) | Spintech, Inc. | 2018-02-23 |
| Wireless Audio System (K173409) | Neocoil, LLC | 2018-02-16 |
| MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit (K173592) | Siemens Medical Solutions USA, Inc. | 2018-02-13 |
| SyMRI (K173558) | Syntheticmr AB | 2018-01-26 |
| Vantage Galan 3T, V4.6 (K173382) | Toshibamedical Systems Corporation | 2018-01-26 |
| 3D APT (K172920) | Philips Medical Systems Nederland B.V. | 2018-01-22 |
| ECHELON OVAL V6.0A MRI System (K172110) | Hitachi Healthcare Americas Corporation | 2018-01-11 |
| MAGNETOM Amira (K173600) | Siemens Medical Solutions USA, Inc. | 2017-12-19 |
| LiverMultiScan (K172685) | Perspectum Diagnostics, Ltd. | 2017-11-21 |
| Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878) | Toshiba Medical Systems Corporation, Japan | 2017-11-17 |
| MAGNETOM Terra (K170840) | Siemens Medical Solutions USA, Inc. | 2017-10-12 |
| SyMRI (K162943) | Syntheticmr AB | 2017-08-29 |
| Vantage Elan 1.5T, V4.0 (K171597) | Toshibamedical Systems Corporation | 2017-07-21 |
| Embrace Neonatal MRI System (K170978) | Aspect Imaging, Ltd. | 2017-07-19 |
| SIGNA Premier (K171128) | Ge Medical Systems, LLC | 2017-07-14 |
| RTHawk, HeartVista Cardiac Package (K170090) | Heartvista, Inc. | 2017-07-14 |
| MAGNETOM Vida (K170396) | Siemens Medical Solutions USA, Inc. | 2017-06-14 |
| Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412) | Toshibamedical Systems Corporation | 2017-06-07 |
| HyperSense (K162722) | Ge Medical Systems, LLC | 2017-04-20 |
| Comfort EC710 (K163192) | Alltech Medical Systems America, Inc. | 2017-04-10 |
| Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331) | Ge Medical Systems, LLC | 2017-03-17 |
| MAGNETOM Sempra with syngo MR E11S (K163211) | Siemens Medical Solutions USA, Inc. | 2017-01-27 |
| MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software (K163312) | Siemens Medical Solutions USA, Inc. | 2017-01-27 |
| Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 (K162931) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116) | Philips Medical Systems Nederland B.V. | 2017-01-06 |
| MultiBand SENSE (K162940) | Philips Medical Systems Nederland B.V. | 2016-12-30 |
| Vantage Galan 3T, MRT-3020, V4.0 (K162183) | Toshibamedical Systems Corporation | 2016-11-25 |
| MAGNETOM Avantofit, MAGNETOM Skyrafit (K162102) | Siemens Medi Cal Solutions, Inc. | 2016-11-22 |
| HyperBand (K162403) | Ge Medical Systems, LLC | 2016-11-18 |
| MAGNETOM ESSENZA (K161795) | Siemens Medical Solutions USA, Inc. | 2016-11-18 |
| G-scan Brio, S-scan (K161973) | Esaote, S.p.A. | 2016-10-25 |
| SIGNA Voyager (K161567) | GE Healthcare | 2016-09-01 |
| MAGiC (K161397) | Ge Medical Systems, LLC | 2016-08-31 |
| Vantage Titan 1.5T, MRT-1510, V3.6 Software (K160632) | Toshibamedical Systems Corporation | 2016-08-23 |
| S-scan (K161238) | Esaote, S.p.A. | 2016-07-08 |
| RTHawk, HeartVista Cardiac Package (K153740) | Heartvista, Inc. | 2016-06-30 |
| Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618) | Ge Medical Systems, LLC | 2016-06-09 |
| Trillium Oval V 5.1 MRI System (K160152) | Hitachi Medical Systems America, Inc. | 2016-05-20 |
| MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (K153343) | Siemens Medi Cal Solutions, Inc. | 2016-04-15 |
| ECHELON Oval V 5.1 MRI System (K153547) | Hitachi Medical Systems America, Inc. | 2016-03-31 |
| MAGNETOM Spectra (K153447) | Siemens Medical Solutions USA, Inc. | 2016-03-31 |
| SIGNAPioneer (K160621) | GE Healthcare | 2016-03-29 |
| Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324) | Philips Medical Systems Nederlands B.V. | 2016-03-22 |
| Wrist 3 (K160185) | Aspect Imaging, Ltd. | 2016-03-01 |
| MRI Dynamic Analysis Plus (K153039) | Esaote, S.p.A. | 2016-01-08 |
| MAGNETOM Amira (K152283) | Siemens Medical Solutions USA, Inc. | 2015-12-24 |
| Magnetic Reasonance Imaging System (K151074) | Jiangsu Magspin Instrument Co.,Ltd | 2015-12-22 |
| SIGNA Pioneer (K153003) | GE Healthcare | 2015-10-27 |
| Vantage Titan 3T (K152371) | Toshibamedical Systems Corporation | 2015-10-23 |
| MrOpen (K151466) | Paramed S.R.L. | 2015-10-15 |
| MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (K151579) | Siemens Medical Solutions USA, Inc. | 2015-09-29 |
| S-scan (K151668) | Esaote, S.p.A. | 2015-09-08 |
| ECHELON Oval V 5.0 MRI System (K151015) | Hitachi Medical Systems America, Inc. | 2015-07-29 |
| SIGNA Pioneer (K143345) | Ge Healthcare Japan Corporation | 2015-07-10 |
| LiverMultiScan (K143020) | Mirada Medical, Ltd. | 2015-06-23 |
| MultiBand SENSE (K143606) | Philips Medical Systems Nethrlands BV | 2015-05-08 |
| Vantage Titan 1.5T, V3.1, MRT-1510 (K150427) | Toshibamedical Systems Corporation | 2015-04-17 |
| Vantage Titan 3T (K143008) | Toshibamedical Systems Corporation | 2015-04-09 |
| G-scan Brio (K142421) | Esaote, S.p.A. | 2015-04-09 |
| O-MAR (K143253) | Philips Medical Systems Nederland B.V. | 2015-04-09 |
| mDIXON XD (K143128) | Philips Medical Systems Nederlands B.V. | 2015-03-20 |
| TRILLIUM Oval MR System (K142734) | Hitachi Medical Systems America, Inc. | 2015-03-02 |
| SIGNA Creator, SIGNA Explorer (K143251) | Ge Healthcare (Ge Medical Systems, LLC) | 2015-02-04 |
| ECHOSTAR COMFORT 1.5T MRI (K141945) | Alltech Medical Systems America, Inc. | 2015-02-03 |
| RTHawk, HeartVista Workstation with RTHawk (K142997) | Heartvista, Inc. | 2014-12-17 |
| Discovery MR750 3.0T (K142361) | Ge Medical Systems, LLC | 2014-12-05 |
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