ClearanceBrief
Panels › Radiology › Product code LNH · Class 2

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)
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Top companies in LNH

Company510(k)sRecalls
Philips North America0236
Siemens Medical Solutions13661
GE Medical Systems8280
GE Healthcare5123
Hitachi Medical Systems America, Inc.5423
Philips Medical Systems Nederlands B.V.367
Toshiba America Mri, Inc.620
Philips Medical Systems (Cleveland), Inc.574
Philips Medical Systems Nederland B.V.2714
Medical Advances, Inc.380
Decided510(k)Device and applicantCode
Feb 24, 2023K213805MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
LNH
Feb 22, 2023K230208Swoop® Portable MR Imaging System™
Hyperfine, Inc.
LNH
Feb 21, 2023K222259NEONA 1.5T MRI System
Time Medical Limited, CN
LNH
Feb 16, 2023K222755uMR 680
Shanghai United Imaging Intelligence Co., Ltd., CN
LNH
Feb 13, 2023K223439SIGNA Victor
Ge Healthcare (Tianjin) Company Limited, CN
LNH
Jan 26, 2023K221619ECHELON Oval V6.2 MRI System
Fujifilm Healthcare Corporation, JP
LNH
Dec 23, 2022K223442MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V., NL
LNH
Dec 6, 2022K223247Swoop Portable MR Imaging System
Hyperfine, Inc.
LNH
Oct 28, 2022K223079Stage
Spintech, Inc.
LNH
Oct 27, 2022K220332uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Oct 25, 2022K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Sep 13, 2022K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
LNH
Sep 6, 2022K213960LiverMultiScan v5 (LMSv5)
Perspectum, GB
LNH
Aug 31, 2022K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Aug 29, 2022K221785TCL3 Motion Tracking System
Tracinnovations A/S, DK
LNH
Jul 28, 2022K221923Swoop Portable MR Imaging System
Hyperfine, Inc.
LNH
Jul 12, 2022K203279Veuron-Brain-mN1
Heuron Co., Ltd., KR
LNH
Jul 1, 2022K221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
Mri Division,Beijing Wandong Medical Technology Co., Ltd., CN
LNH
Jun 24, 2022K220575MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
LNH
Jun 10, 2022K221393Swoop Portable MR Imaging System
Hyperfine, Inc.
LNH
Jun 8, 2022K213717AIR Recon DL
Ge Medical Systems,Llc (Ge Healthcare)
LNH
May 16, 2022K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V., NL
LNH
May 13, 2022K220589MAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc.
LNH
Apr 29, 2022K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
LNH
Apr 8, 2022K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Apr 5, 2022K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Apr 1, 2022K220151MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.
LNH
Mar 11, 2022K220425MAGNETOM Vida, MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
LNH
Mar 3, 2022K220018MR Elastography; MZEK-001A
Canon Medical Systems Corporation, JP
LNH
Mar 3, 2022K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Philips Medical Systems Nederland B.V., NL
LNH
Feb 25, 2022K213693MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
LNH
Feb 11, 2022K213603SIGNA Artist Evo
Ge Healthcare (Tianjin) Company Limited, CN
LNH
Feb 4, 2022K212419Magnifico Open, Magnifico MSK
Esaote, S.p.A., IT
LNH
Feb 4, 2022K212271smart-sync
Northh Medical GmbH, DE
LNH
Jan 20, 2022K213668SIGNA Hero
Ge Healthcare (Ge Medical Systems, LLC)
LNH
Jan 16, 2022K211980SIGNA Prime
Ge Healthcare (Tianjin) Company Limited, CN
LNH
Dec 1, 2021K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Nov 24, 2021K211983AMRA Profiler
Amra Medical AB, SE
LNH
Nov 19, 2021K212673MR 5300
Philips Medical Systems Nederland B.V., NL
LNH
Nov 17, 2021K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
LNH
Nov 3, 2021K203372SyMRI
Syntheticmr AB, SE
LNH
Oct 7, 2021K211406OASIS MRI System
Hitachi Healthcare Americas
LNH
Oct 5, 2021K212233RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
LNH
Aug 23, 2021K212367IMRIS iMRI 3T V
Deerfield Imaging, Inc.
LNH
Aug 4, 2021K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Jul 22, 2021K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Jul 22, 2021K210415QSM software, QSMetric
Medimagemetric, LLC
LNH
Jul 7, 2021K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
LNH
Jul 1, 2021K210611MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.
LNH
Jun 29, 2021K210843STAGE
Spintech, Inc.
LNH

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