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..
1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
Cleared
Feb 06, 2020
Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc.
Radiology
195d
Cleared
Feb 04, 2020
Motion Correction System
Kineticor, Inc.
Radiology
64d
Cleared
Jan 06, 2020
MRIaudio PREM System with MRIview
Mriaudio, Inc.
Radiology
59d
Cleared
Dec 20, 2019
MRopen EVO
Asg Superconductors S.P.A.
Radiology
38d
Cleared
Nov 27, 2019
fMRI Hardware System
Nordicneurolab AS
Radiology
223d
Cleared
Oct 24, 2019
Upgrade Kit MR GUI PRO, MrJ 3300 Plus
Asg Superconductors S.P.A.
Radiology
28d
Cleared
Oct 18, 2019
RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
Radiology
329d
Cleared
Oct 01, 2019
Signa Voyager, Signa Voyager Quantum
Ge Healthcare (Tianjin) Company Limited
Radiology
26d
Cleared
Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
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
Siemens Medical Solutions USA, Inc.
Radiology
84d
Cleared
Jul 01, 2019
MRopen 0.5 T
Asg Superconductors S.P.A.
Radiology
119d
Cleared
Jun 27, 2019
LiverMultiScan (LMSv3)
Perspectum Diagnostics, Ltd.
Radiology
175d
Cleared
Jun 26, 2019
Vantage Titan 3T, MRT-3010, V2.5
Canon Medical Systems Corporation
Radiology
58d
Cleared
Jun 13, 2019
SyMRI
Syntheticmr AB
Radiology
56d
Cleared
Jun 04, 2019
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Philips Medical Systems Nederland B.V.
Radiology
98d
Cleared
May 31, 2019
MAGNETOM Avanto Fit
Siemens Medical Solution USA, Inc.
Radiology
67d
Cleared
May 29, 2019
uMR 780, uMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
28d
Cleared
Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
Canon Medical Systems Corporation
Radiology
78d
Cleared
Feb 22, 2019
EMMA 1.5T MRI System
Time Medical Limited
Radiology
58d
Cleared
Feb 15, 2019
MAGNETOM Terra
Siemens Medical Solutions USA, Inc.
Radiology
87d
Cleared
Feb 15, 2019
MAGNETOM Aera
Siemens Medical Solutions USA, Inc.
Radiology
17d
Cleared
Feb 14, 2019
MyoStrain 5.1
Myocardial Solutions
Radiology
139d
Cleared
Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Radiology
101d
Cleared
Feb 14, 2019
MAGNETOM Amira, MAGNETOM Sempra
Siemens Medical Solutions USA, Inc.
Radiology
86d