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
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
Cleared
Oct 12, 2018
MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Oct 05, 2018
MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
140d
Cleared
Oct 03, 2018
uMR 780
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
133d
Cleared
Oct 03, 2018
uMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
133d
Cleared
Aug 13, 2018
Vantage Galan 3T, MRT-3020/A7, V5.0
Canon Medical Systems Corporation
Radiology
56d
Cleared
Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
Philips Medical Systems Nederland B.V.
Radiology
59d
Cleared
Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
Philips Healthcare (Suzhou) Co., Ltd.
Radiology
214d
Cleared
Jun 14, 2018
MRIaudio PREM System
Mriaudio
Radiology
149d
Cleared
Jun 12, 2018
SyMRI
Syntheticmr AB
Radiology
48d
Cleared
Jun 06, 2018
uMR 570
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
58d
Cleared
Jun 06, 2018
uMR 560
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
58d
Cleared
Apr 04, 2018
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Philips Medical Systems Nederland B.V.
Radiology
187d
Cleared
Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Siemens Medical Solutions USA, Inc.
Radiology
128d
Cleared
Mar 30, 2018
G-scan Brio
Esaote, S.P.A.
Radiology
24d