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
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
Cleared
Jan 24, 2019
MAGNETOM Lumina
Siemens Medical Solutions USA, Inc.
Radiology
64d
Cleared
Jan 22, 2019
O-Scan
Esaote, S.P.A.
Radiology
25d
Cleared
Jan 18, 2019
SIGNA Premier
Ge Medical Systems, LLC
Radiology
59d
Cleared
Jan 18, 2019
Magnetom Vida
Siemens Medical Solutions USA, Inc.
Radiology
58d
Cleared
Jan 11, 2019
uMR 580, uMR 588
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
59d
Cleared
Dec 06, 2018
AMRA Profiler
Amra Medical AB
Radiology
363d
Cleared
Nov 06, 2018
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
Siemens Medical Solutions USA, Inc.
Radiology
140d
Cleared
Oct 26, 2018
MAGNETOM Aera
Siemens Medical Solutions USA, Inc.
Radiology
63d
Cleared
Oct 19, 2018
MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
Radiology
140d
Cleared
Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
Canon Medical Systems Corporation
Radiology
57d