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
DateFirm and productCodeLinked 510(k)
Jan 29, 2026Philips North America
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
K213583
Jan 29, 2026Philips North America
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
Jan 29, 2026Philips North America
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
Jan 29, 2026Philips North America
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
Jan 29, 2026Philips North America
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK193215
Jan 29, 2026Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK213583
Jan 29, 2026Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Open, Classified		 LNHK213583
K251808
Jan 13, 2026Canon Medical System, USA, INC.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Open, Classified		 LNHK191128
Jan 13, 2026Canon Medical System, USA, INC.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Open, Classified		 LNHK230355
Nov 12, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Open, Classified		 LNHK231587
Oct 28, 2025IMPRIS Imaging Inc
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Open, Classified		 LNHK083137
K101813 +2
Oct 28, 2025IMPRIS Imaging Inc
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Open, Classified		 LNHK083137
K101813 +2
Oct 28, 2025IMPRIS Imaging Inc
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
Open, Classified		 LNHK083137
K101813 +2
Oct 28, 2025IMPRIS Imaging Inc
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Open, Classified		 LNHK083137
K101813 +2
Oct 24, 2025Canon Medical System, USA, INC.
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Open, Classified		 LNHK243335
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Open, Classified		 LNHK192924
K220939
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Open, Classified		 LNHK170396
K231560
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Open, Classified		 LNHK121434
K181613
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio Dot. Model Number: 10684333.
Open, Classified		 LNHK121434
K181613
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Verio. Model Number: 10276755.
Open, Classified		 LNHK072237
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Open, Classified		 LNHK121160
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Open, Classified		 LNHK220589
K232494 +1
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Open, Classified		 LNHK130885
K151579 +4
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Open, Classified		 LNHK101347
K231560
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Prisma. Model Number: 10849582.
Open, Classified		 LNHK132119
K151579 +4
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Open, Classified		 LNHK183244
K192924 +2
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Connectom.X. Model Number: 11371480.
Open, Classified		 LNHNone listed
Sep 30, 2025Siemens Medical Solutions USA, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Open, Classified		 LNHNone listed
Sep 30, 2025Siemens Medical Solutions USA, Inc
BIOGRAPH One (DE). Model Number: 11689172.
Open, Classified		 LNHK101347
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK213603
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
Open, Classified		 LNHK142098
K163619 +1
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK213668
Aug 13, 2025GE Medical Systems, LLC
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK142085
K160618 +1
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK171128
K183231 +1
Aug 13, 2025GE Medical Systems, LLC
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK160618
K163331 +1
Aug 13, 2025GE Medical Systems, LLC
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK132376
K142085 +2
Aug 13, 2025GE Medical Systems, LLC
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK142085
K160618 +1
Aug 13, 2025GE Medical Systems, LLC
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
Open, Classified		 LNHK161567
K192426

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