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
Oct 9, 2026K262902ECHELON Synergy
Fujifilm Corporation, JP
LNH
Oct 7, 2026K260092Vista AI Scan
Vista AI, Inc.
LNH
Oct 1, 2026K261612SwiftSight-BodyComposition
Airs Medical, Inc., KR
LNH
Sep 16, 2026K261758Embrace Vision Neonatal MRI System
Aspect Imaging, Ltd., IL
LNH
Sep 16, 2026K261283APERTO Lucent MRI System
Fujifilm Corporation, JP
LNH
Sep 1, 2026K260758MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd., CN
LNH
Aug 19, 2026K262622Swoop® Portable MR Imaging® System
Hyperfine, Inc.
LNH
Aug 17, 2026K254250MagicScan-1.5, GreenMR Serenity 1.5T
Xingaoyi Medical Equipment Co.,Ltd, CN
LNH
Aug 13, 2026K253808AIR Recon DL
GE Medical Systems
LNH
Jul 31, 2026K261331I-Genius (100019400)
Esaote, S.p.A., IT
LNH
Jul 31, 2026K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
Siemens Healthineers AG, DE
LNH
May 22, 2026K260113uMR Astra
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Apr 6, 2026K253862APERTO Lucent MRI System
Fujifilm Corporation, JP
LNH
Mar 27, 2026K260746S-scan Open (100001800)
Esaote, S.p.A., IT
LNH
Mar 27, 2026K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Mar 20, 2026K251937nordicAudio (1.0)
Nordicneurolab AS, NO
LNH
Mar 13, 2026K254277Embrace Neonatal MRI System
Aspect Imaging, Ltd., IL
LNH
Mar 9, 2026K253413LiverMultiScan (v6.0)
Perspectum, Ltd., GB
LNH
Mar 5, 2026K251901Magnifico Open (100009900)
Esaote, S.p.A., IT
LNH
Feb 23, 2026K260265MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance , Ltd., CN
LNH
Feb 23, 2026K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems includ
Philips Medical Systems Nederland B.V., NL
LNH
Feb 6, 2026K253780SIGNA™ Bolt
Ge Medical Systems, LLC
LNH
Feb 5, 2026K253779SIGNA™ Sprint Select
Ge Medical Systems, LLC
LNH
Jan 26, 2026K253499Ascent3T Neonatal Magnetic Resonance Imaging System
Eyas Medical Imaging, Inc.
LNH
Dec 23, 2025K252379AIR Recon DL
Ge Medical Systems, LLC
LNH
Dec 19, 2025K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida F
Siemens Healthcare GmbH, DE
LNH
Dec 12, 2025K253489Swoop® Portable MR Imaging® System
Hyperfine, Inc.
LNH
Nov 20, 2025K251822MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd., CN
LNH
Sep 25, 2025K252371uMR 680
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Sep 17, 2025K251386ECHELON Synergy
Fujifilm Corporation, JP
LNH
Sep 11, 2025K251399SIGNA™ Sprint
Ge Medical Systems, LLC
LNH
Sep 9, 2025K251682MuscleView 2.0
Springbok, Inc. (Dba Springbok Analytics)
LNH
Aug 21, 2025K251029Vista OS, Vista AI Scan, RTHawk
Vista AI, Inc.
LNH
Aug 6, 2025K252239InVision™ 3T Recharge Operating Suite
Imris Imaging, Inc.
LNH
Aug 5, 2025K250246uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Jul 22, 2025K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH
Jul 17, 2025K243547uMR Ultra
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Jul 16, 2025K243397uMR 680
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Jul 11, 2025K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ing
Philips Medical Systems Nederland B.V., NL
LNH
Jun 16, 2025K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH, DE
LNH
Jun 16, 2025K250436MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance , Ltd., CN
LNH
Jun 5, 2025K243667Sonic DL
Ge Medical Systems, LLC
LNH
Jun 4, 2025K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V., NL
LNH
May 30, 2025K250236Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
LNH
May 21, 2025K251276Swoop® Portable MR Imaging® System
Hyperfine, Inc.
LNH
May 21, 2025K243122uMR Omega
Shanghai United Imaging Healthcare Co., Ltd., CN
LNH
Mar 17, 2025K250379SIGNA Prime Elite
Ge Medical Systems, LLC
LNH
Feb 12, 2025K242006SureWave Elastography (Q7000225)
Quality Electrodynamics, LLC
LNH
Jan 17, 2025K242825Prenuvo Body Composition
Prenuvo
LNH
Jan 7, 2025K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation, JP
LNH

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