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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)
Jun 4, 2021Philips North America Llc
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
Open, Classified		 LNHK181479
Jun 4, 2021Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Open, Classified		 LNHK181479
May 21, 2021Canon Medical System, USA, INC.
Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic struct
Open, Classified		 LNHK203553
May 21, 2021Canon Medical System, USA, INC.
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique image
Open, Classified		 LNHK172878
May 21, 2021Canon Medical System, USA, INC.
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique im
Open, Classified		 LNHK170412
May 21, 2021Canon Medical System, USA, INC.
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal,
Open, Classified		 LNHK122613
Sep 8, 2020GE Healthcare, LLC
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Terminated		 LNHK160618
K163331
Sep 8, 2020GE Healthcare, LLC
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Terminated		 LNHK160618
K163331
Sep 8, 2020GE Healthcare, LLC
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Terminated		 LNHK091536
K163331
Sep 8, 2020GE Healthcare, LLC
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Terminated		 LNHK103327
K163331
Feb 6, 2020Invivo Corporation
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Terminated		 LNHK023130
Jan 28, 2020GE Healthcare, LLC
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hig
Terminated		 LNHK052293
K121676
Jan 28, 2020GE Healthcare, LLC
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time
Terminated		 LNHK143345
K153003 +1
Jan 28, 2020GE Healthcare, LLC
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan ti
Terminated		 LNHK163331
Jan 28, 2020GE Healthcare, LLC
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time
Terminated		 LNHK171128
Nov 26, 2019Deerfield Imaging, Inc.
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens A
Terminated		 LNHK101813
Jul 9, 2019Siemens Medical Solutions USA, Inc
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Terminated		 LNHK132119
Jul 9, 2019Siemens Medical Solutions USA, Inc
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Terminated		 LNHK121160
Jul 9, 2019Siemens Medical Solutions USA, Inc
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Terminated		 LNHK111242
Jul 9, 2019Siemens Medical Solutions USA, Inc
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
Terminated		 LNHK111242
Mar 25, 2019Philips Medical Systems Nederlands
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply p
Terminated		 LNHK181479
Feb 22, 2019Philips Medical Systems Nederlands
Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK110151
Feb 22, 2019Philips Medical Systems Nederlands
MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK110151
Feb 22, 2019Philips Medical Systems Nederlands
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK110151
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK173356
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK173356
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK181479
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK181479
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK163116
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK163116
Feb 22, 2019Philips Medical Systems Nederlands
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK041602
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK153324
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK052013
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK052013
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK163116
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK052013
Feb 22, 2019Philips Medical Systems Nederlands
Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK052013
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK043147
Feb 22, 2019Philips Medical Systems Nederlands
Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHK162931

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