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
Dec 23, 2024K242573NIDO Baby Magnetic Resonance Imaging System
Jiangsu Lici Medical Device Co., Ltd., CN
LNH
Dec 6, 2024K242524SyMRI
Syntheticmr AB (Publ.), SE
LNH
Nov 26, 2024K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
Asg Superconductors S.P.A., IT
LNH
Oct 17, 2024K241242SIGNA MAGNUS
Ge Medical Systems, LLC
LNH
Oct 2, 2024K241925VitruvianScan (v1.0)
Perspectum, Ltd., GB
LNH
Oct 1, 2024K241331MuscleView
Springbok, Inc.
LNH
Aug 26, 2024K241607MyoStrain (6.0)
Myocardial Solutions, Inc.
LNH
Aug 20, 2024K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Aug 13, 2024K241429ECHELON Synergy MRI System
Fujifilm Healthcare Corporation, JP
LNH
Jul 22, 2024K231133neo315
Neoscan Solution GmbH, DE
LNH
Jul 16, 2024K240944Swoop® Portable MR Imaging® System
Hyperfine, Inc.
LNH
Jun 26, 2024K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)
Esaote, S.p.A., IT
LNH
May 10, 2024K233629APERTO Lucent MRI System
FUJIFILM Healthcare Americas Corporation
LNH
May 3, 2024K233687ECHELON Synergy V10.0
FUJIFILM Healthcare Americas Corporation
LNH
Apr 26, 2024K233673uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Apr 12, 2024K240571OASIS MRI System
Fujifilm Healthcare Corporation, JP
LNH
Apr 12, 2024K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Apr 10, 2024K240744uMR 680
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Mar 29, 2024K240608MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
LNH
Mar 26, 2024K233733SyMRI
Syntheticmr AB (Publ.), SE
LNH
Mar 22, 2024K240540uMR Omega
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Mar 22, 2024K232322MAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.
LNH
Feb 29, 2024K232765MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
LNH
Feb 15, 2024K240157InVision™ 1.5 Surgical Theatre
Deerfield Imaging, Inc.
LNH
Feb 8, 2024K232644neuro42 MRI System
Neuro42, Inc.
LNH
Jan 19, 2024K233728SIGNA Champion
Ge Healthcare (Tianjin) Company Limited, CN
LNH
Dec 22, 2023K232535MAGNETOM Sola; MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
LNH
Dec 18, 2023K231587MAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.
LNH
Dec 13, 2023K232680fMRI Hardware System
Nordicneurolab AS, NO
LNH
Nov 14, 2023K232494MAGNETOM Avanto fit; MAGNETOM Skyra fit
Siemens Medical Solutions USA, Inc.
LNH
Nov 9, 2023K231617MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
LNH
Oct 27, 2023K232346Digital Expert Access with Remote Scanning
GE Healthcare
LNH
Oct 23, 2023K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.
LNH
Oct 11, 2023K232981Synq Software Version 1.3
Synaptive Medical, Inc., CA
LNH
Oct 6, 2023K232760Swoop® Portable MR Imaging System®
Hyperfine, Inc.
LNH
Sep 29, 2023K230187Terran NM-101
Terran Biosciences, Inc.
LNH
Sep 6, 2023K232482MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
LNH
Sep 5, 2023K232361Promaxo MRI System II
Promaxo, Inc.
LNH
Aug 30, 2023K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Aug 2, 2023K232030Ingenia Elition R5.7.1 SP4 MR Systems
Philips Medical Systems Nederland B.V., NL
LNH
Jul 13, 2023K223426ECHELON Synergy MRI system
Fujifilm Healthcare Corporation, JP
LNH
Jun 20, 2023K231459HepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty, Ltd., AU
LNH
May 30, 2023K223523Sonic DL
Ge Medical Systems,Llc (Ge Healthcare)
LNH
May 23, 2023K230152uMR Omega
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
May 18, 2023K230758uMR 570
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Apr 28, 2023K230972Ingenia Elition and MR 7700 MR Systems
Philips Medical Systems Nederland B.V., NL
LNH
Apr 6, 2023K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland B.V., NL
LNH
Mar 28, 2023K223343MAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA, Inc.
LNH
Mar 20, 2023K223875MOBINEURO Alita Intraoperative MRI System
Sino Canada Health Engineering Research Institute (Hefei), CN
LNH
Mar 2, 2023K2232031.5T 24E Posterior Array
Shenzhen RF Tech Co., Ltd., CN
LNH

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