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
May 17, 2021K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
May 13, 2021K211118SIGNA 7.0T
Ge Medical Systems, LLC
LNH
Apr 28, 2021K203451TCL3 Motion Tracking System
Tracinnovations Aps, DK
LNH
Apr 1, 2021K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Mar 31, 2021K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
LNH
Mar 10, 2021K210164Vantage Elan 1.5T, MRT-2020, V6.0
Canon Medical Systems Corporation, JP
LNH
Mar 4, 2021K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Mar 3, 2021K202518Promaxo MRI System
Promaxo, Inc.
LNH
Mar 2, 2021K203653MRI PPG Patient Cable
Ivy Biomedical Systems, Inc.
LNH
Feb 2, 2021K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Jan 29, 2021K192650i_Space 1.5T Superconducting Magnetic Resonance Imaging System
Mri Division,Beijing Wandong Medical Technology Co., Ltd., CN
LNH
Jan 15, 2021K202767Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation, JP
LNH
Jan 12, 2021K203280Hepatica v1 (Hepatica v1.0.0)
Perspectum, Ltd., GB
LNH
Dec 7, 2020K201039HepaFat-AI
Resonance Health Analysis Services Pty, Ltd., AU
LNH
Dec 2, 2020K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Nov 13, 2020K202966SIGNA Architect
Ge Healthcare (Ge Medical Systems, LLC)
LNH
Oct 21, 2020K202030OASIS MRI System
Hitachi Healthcare Americas
LNH
Oct 15, 2020K201615SIGNA 7.0T
Ge Medical Systems, LLC
LNH
Oct 2, 2020K202170LiverMultiScan
Perspectum, Ltd., GB
LNH
Sep 22, 2020K202210Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation, JP
LNH
Sep 8, 2020K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
Siemens Medical Solutions USA, Inc.
LNH
Sep 4, 2020K202238SIGNA Artist
Ge Healthcare (Tianjin) Company Limited, CN
LNH
Aug 26, 2020K201141FIRMM
Nous Imaging, Inc.
LNH
Aug 11, 2020K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine Research, Inc.
LNH
Jul 28, 2020K201616SyMRI
Syntheticmr AB, SE
LNH
Jul 14, 2020K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Jul 10, 2020K201389Resoundant Acoustic Driver System
Resoundant, Inc.
LNH
Jul 6, 2020K201540uMR570
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Jun 3, 2020K193021Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation, JP
LNH
May 5, 2020K193176uMR 780
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Apr 29, 2020K200327Evry
Synaptive Medical, Inc., CA
LNH
Apr 20, 2020K200024uMR 570
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Apr 10, 2020K193282SIGNA Premier
Ge Healthcare (Ge Medical Systems, LLC)
LNH
Apr 10, 2020K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V., NL
LNH
Apr 7, 2020K193218Innovision Audio
Innovere Medical, Inc., CA
LNH
Mar 28, 2020K192852MRI ECG Patient Cable
Ivy Biomedical Systems, Inc.
LNH
Mar 27, 2020K193200uMR Omega
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Mar 11, 2020K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
Siemens Medical Solutions USA, Inc.
LNH
Mar 9, 2020K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Mar 2, 2020K192506Vantage Galan 3T, MRT-3020, V6.0
Canon Medical Systems Corporation, JP
LNH
Feb 28, 2020K192496Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Siemens Medical Solutions USA, Inc.
LNH
Feb 21, 2020K192851OASIS MRI System
Hitachi Healthcare Americas
LNH
Feb 6, 2020K192002Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc.
LNH
Feb 4, 2020K193324Motion Correction System
Kineticor, Inc.
LNH
Jan 6, 2020K193102MRIaudio PREM System with MRIview
Mriaudio, Inc.
LNH
Dec 20, 2019K193116MRopen EVO
Asg Superconductors S.P.A., IT
LNH
Nov 27, 2019K191032fMRI Hardware System
Nordicneurolab AS, NO
LNH
Oct 24, 2019K192690Upgrade Kit MR GUI PRO, MrJ 3300 Plus
Asg Superconductors S.P.A., IT
LNH
Oct 18, 2019K183274RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
LNH
Oct 1, 2019K192426Signa Voyager, Signa Voyager Quantum
Ge Healthcare (Tianjin) Company Limited, CN
LNH

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