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
Jun 03, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Radiology
217d
Cleared
May 05, 2020
uMR 780
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
169d
Cleared
Apr 29, 2020
Evry
Synaptive Medical, Inc.
Radiology
79d
Cleared
Apr 20, 2020
uMR 570
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
105d
Cleared
Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Radiology
141d
Cleared
Apr 10, 2020
SIGNA Premier
Ge Healthcare (Ge Medical Systems, LLC)
Radiology
135d
Cleared
Apr 07, 2020
Innovision Audio
Innovere Medical, Inc.
Radiology
138d
Cleared
Mar 28, 2020
MRI ECG Patient Cable
Ivy Biomedical Systems, Inc.
Cardiovascular
177d
Cleared
Mar 27, 2020
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
128d
Cleared
Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
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
Canon Medical Systems Corporation
Radiology
172d
Cleared
Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
Canon Medical Systems Corporation
Radiology
172d
Cleared
Feb 28, 2020
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Siemens Medical Solutions USA, Inc.
Radiology
170d
Cleared
Feb 21, 2020
OASIS MRI System
Hitachi Healthcare Americas
Radiology
141d
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