LNH · Class II · 21 CFR 892.1000

FDA Product Code LNH: System, Nuclear Magnetic Resonance Imaging

FDA product code LNH covers magnetic resonance imaging (MRI) systems.

These diagnostic imaging systems use strong magnetic fields and radiofrequency pulses to generate detailed cross-sectional images of soft tissue, organs, and musculoskeletal structures without ionizing radiation. MRI is widely used in neurology, oncology, and orthopedics.

LNH devices are Class II medical devices, regulated under 21 CFR 892.1000 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Mri, Inc. and Philips Medical Systems (Cleveland), Inc..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
169–192 of 1101
Cleared Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K193021
Canon Medical Systems Corporation
Radiology · 217d
Cleared May 05, 2020
uMR 780
K193176
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 169d
Cleared Apr 29, 2020
Evry
K200327
Synaptive Medical, Inc.
Radiology · 79d
Cleared Apr 20, 2020
uMR 570
K200024
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 105d
Cleared Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K193215
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 10, 2020
SIGNA Premier
K193282
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 07, 2020
Innovision Audio
K193218
Innovere Medical, Inc.
Radiology · 138d
Cleared Mar 28, 2020
MRI ECG Patient Cable
K192852
Ivy Biomedical Systems, Inc.
Cardiovascular · 177d
Cleared Mar 27, 2020
uMR Omega
K193200
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 128d
Cleared Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
K192924
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K192574
Canon Medical Systems Corporation
Radiology · 172d
Cleared Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
K192506
Canon Medical Systems Corporation
Radiology · 172d
Cleared Feb 28, 2020
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
K192496
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Feb 21, 2020
OASIS MRI System
K192851
Hitachi Healthcare Americas
Radiology · 141d
Cleared Feb 06, 2020
Lucy Point-of-Care Magnetic Resonance Imaging Device
K192002
Hyperfine Research, Inc.
Radiology · 195d
Cleared Feb 04, 2020
Motion Correction System
K193324
Kineticor, Inc.
Radiology · 64d
Cleared Jan 06, 2020
MRIaudio PREM System with MRIview
K193102
Mriaudio, Inc.
Radiology · 59d
Cleared Dec 20, 2019
MRopen EVO
K193116
Asg Superconductors S.P.A.
Radiology · 38d
Cleared Nov 27, 2019
fMRI Hardware System
K191032
Nordicneurolab AS
Radiology · 223d
Cleared Oct 24, 2019
Upgrade Kit MR GUI PRO, MrJ 3300 Plus
K192690
Asg Superconductors S.P.A.
Radiology · 28d
Cleared Oct 18, 2019
RTHawk, HeartVista Cardiac Package
K183274
Heartvista, Inc.
Radiology · 329d
Cleared Oct 01, 2019
Signa Voyager, Signa Voyager Quantum
K192426
Ge Healthcare (Tianjin) Company Limited
Radiology · 26d
Cleared Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
K191662
Canon Medical Systems Corporation
Radiology · 32d
Cleared Jul 12, 2019
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
K191050
Siemens Medical Solutions USA, Inc.
Radiology · 84d