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LNH

1,101 FDA 510(k) clearances · Product code

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RecordFirmDate
uMR Omega with uWS-MR-MRS (K220332)Shanghai United Imaging Healthcare Co., Ltd.2022-10-27
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K222968)Canon Medical Systems Corporation2022-10-25
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit (K221733)Siemens Medical Solutions USA, Inc.2022-09-13
LiverMultiScan v5 (LMSv5) (K213960)Perspectum2022-09-06
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K222387)Canon Medical Systems Corporation2022-08-31
TCL3 Motion Tracking System (K221785)Tracinnovations A/S2022-08-29
Swoop Portable MR Imaging System (K221923)Hyperfine, Inc.2022-07-28
Veuron-Brain-mN1 (K203279)Heuron Co., Ltd.2022-07-12
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System (K221025)Mri Division,Beijing Wandong Medical Technology Co., Ltd.2022-07-01
MAGNETOM Free.Max, MAGNETOM Free.Star (K220575)Siemens Medical Solutions USA, Inc.2022-06-24
Swoop Portable MR Imaging System (K221393)Hyperfine, Inc.2022-06-10
AIR Recon DL (K213717)Ge Medical Systems,Llc (Ge Healthcare)2022-06-08
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583)Philips Medical Systems Nederland B.V.2022-05-16
MAGNETOM Skyra Fit (K220589)Siemens Medical Solutions USA, Inc.2022-05-13
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A (K220939)Siemens Medical Solutions USA, Inc.2022-04-29
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192)Canon Medical Systems Corporation2022-04-08
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335)Canon Medical Systems Corporation2022-04-05
MAGNETOM Avanto Fit (K220151)Siemens Medical Solutions USA, Inc.2022-04-01
MAGNETOM Vida, MAGNETOM Sola (K220425)Siemens Medical Solutions USA, Inc.2022-03-11
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei (K213516)Philips Medical Systems Nederland B.V.2022-03-03
MR Elastography; MZEK-001A (K220018)Canon Medical Systems Corporation2022-03-03
MAGNETOM Vida with syngo MR XA50A (K213693)Siemens Medical Solutions USA, Inc.2022-02-25
SIGNA Artist Evo (K213603)Ge Healthcare (Tianjin) Company Limited2022-02-11
Magnifico Open, Magnifico MSK (K212419)Esaote, S.p.A.2022-02-04
smart-sync (K212271)Northh Medical GmbH2022-02-04
SIGNA Hero (K213668)Ge Healthcare (Ge Medical Systems, LLC)2022-01-20
SIGNA Prime (K211980)Ge Healthcare (Tianjin) Company Limited2022-01-16
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305)Canon Medical Systems Corporation2021-12-01
AMRA Profiler (K211983)Amra Medical AB2021-11-24
MR 5300 (K212673)Philips Medical Systems Nederland B.V.2021-11-19
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456)Hyperfine, Inc.2021-11-17
SyMRI (K203372)Syntheticmr AB2021-11-03
OASIS MRI System (K211406)Hitachi Healthcare Americas2021-10-07
RTHawk, HeartVista Cardiac Package (K212233)Heartvista, Inc.2021-10-05
IMRIS iMRI 3T V (K212367)Deerfield Imaging, Inc.2021-08-23
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K212056)Canon Medical Systems Corporation2021-08-04
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633)Canon Medical Systems Corporation2021-07-22
QSM software, QSMetric (K210415)Medimagemetric, LLC2021-07-22
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K211818)Hyperfine, Inc.2021-07-07
MAGNETOM Free.Max (K210611)Siemens Medical Solutions USA, Inc.2021-07-01
STAGE (K210843)Spintech, Inc.2021-06-29
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K211037)Canon Medical Systems Corporation2021-05-17
SIGNA 7.0T (K211118)Ge Medical Systems, LLC2021-05-13
TCL3 Motion Tracking System (K203451)Tracinnovations Aps2021-04-28
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K210340)Canon Medical Systems Corporation2021-04-01
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea (K203443)Siemens Medical Solutions USA, Inc.2021-03-31
Vantage Elan 1.5T, MRT-2020, V6.0 (K210164)Canon Medical Systems Corporation2021-03-10
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K203323)Canon Medical Systems Corporation2021-03-04
Promaxo MRI System (K202518)Promaxo, Inc.2021-03-03
MRI PPG Patient Cable (K203653)Ivy Biomedical Systems, Inc.2021-03-02
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553)Canon Medical Systems Corporation2021-02-02
i_Space 1.5T Superconducting Magnetic Resonance Imaging System (K192650)Mri Division,Beijing Wandong Medical Technology Co., Ltd.2021-01-29
Vantage Orian 1.5T, MRT-1550, V6.0 (K202767)Canon Medical Systems Corporation2021-01-15
Hepatica v1 (Hepatica v1.0.0) (K203280)Perspectum, Ltd.2021-01-12
HepaFat-AI (K201039)Resonance Health Analysis Services Pty, Ltd.2020-12-07
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K203053)Canon Medical Systems Corporation2020-12-02
SIGNA Architect (K202966)Ge Healthcare (Ge Medical Systems, LLC)2020-11-13
OASIS MRI System (K202030)Hitachi Healthcare Americas2020-10-21
SIGNA 7.0T (K201615)Ge Medical Systems, LLC2020-10-15
LiverMultiScan (K202170)Perspectum, Ltd.2020-10-02
Vantage Orian 1.5T, MRT-1550, V6.0 (K202210)Canon Medical Systems Corporation2020-09-22
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit (K202014)Siemens Medical Solutions USA, Inc.2020-09-08
SIGNA Artist (K202238)Ge Healthcare (Tianjin) Company Limited2020-09-04
FIRMM (K201141)Nous Imaging, Inc.2020-08-26
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K201722)Hyperfine Research, Inc.2020-08-11
SyMRI (K201616)Syntheticmr AB2020-07-28
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097)Canon Medical Systems Corporation2020-07-14
Resoundant Acoustic Driver System (K201389)Resoundant, Inc.2020-07-10
uMR570 (K201540)Shanghai United Imaging Healthcare Co., Ltd.2020-07-06
Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)Canon Medical Systems Corporation2020-06-03
uMR 780 (K193176)Shanghai United Imaging Healthcare Co., Ltd.2020-05-05
Evry (K200327)Synaptive Medical, Inc.2020-04-29
uMR 570 (K200024)Shanghai United Imaging Healthcare Co., Ltd.2020-04-20
SIGNA Premier (K193282)Ge Healthcare (Ge Medical Systems, LLC)2020-04-10
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215)Philips Medical Systems Nederland B.V.2020-04-10
Innovision Audio (K193218)Innovere Medical, Inc.2020-04-07
MRI ECG Patient Cable (K192852)Ivy Biomedical Systems, Inc.2020-03-28
uMR Omega (K193200)Shanghai United Imaging Healthcare Co., Ltd.2020-03-27
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit (K192924)Siemens Medical Solutions USA, Inc.2020-03-11
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574)Canon Medical Systems Corporation2020-03-09
Vantage Galan 3T, MRT-3020, V6.0 (K192506)Canon Medical Systems Corporation2020-03-02
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit (K192496)Siemens Medical Solutions USA, Inc.2020-02-28
OASIS MRI System (K192851)Hitachi Healthcare Americas2020-02-21
Lucy Point-of-Care Magnetic Resonance Imaging Device (K192002)Hyperfine Research, Inc.2020-02-06
Motion Correction System (K193324)Kineticor, Inc.2020-02-04
MRIaudio PREM System with MRIview (K193102)Mriaudio, Inc.2020-01-06
MRopen EVO (K193116)Asg Superconductors S.P.A.2019-12-20
fMRI Hardware System (K191032)Nordicneurolab AS2019-11-27
Upgrade Kit MR GUI PRO, MrJ 3300 Plus (K192690)Asg Superconductors S.P.A.2019-10-24
RTHawk, HeartVista Cardiac Package (K183274)Heartvista, Inc.2019-10-18
Signa Voyager, Signa Voyager Quantum (K192426)Ge Healthcare (Tianjin) Company Limited2019-10-01
Vantage Orian 1.5T, MRT-1550, V4.5 (K191662)Canon Medical Systems Corporation2019-07-23
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow (K191050)Siemens Medical Solutions USA, Inc.2019-07-12
MRopen 0.5 T (K190524)Asg Superconductors S.P.A.2019-07-01
LiverMultiScan (LMSv3) (K190017)Perspectum Diagnostics, Ltd.2019-06-27
Vantage Titan 3T, MRT-3010, V2.5 (K191128)Canon Medical Systems Corporation2019-06-26
SyMRI (K191036)Syntheticmr AB2019-06-13
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems (K190461)Philips Medical Systems Nederland B.V.2019-06-04
MAGNETOM Avanto Fit (K190757)Siemens Medical Solution USA, Inc.2019-05-31
uMR 780, uMR 790 (K191157)Shanghai United Imaging Healthcare Co., Ltd.2019-05-29
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