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 Canon Medical Systems Corporation, Siemens Medical Solutions USA, Inc. and Shanghai United Imaging Healthcare Co., Ltd..
1098
Total
1098
Cleared
110d
Avg days
1988
Since
1098 devices
Cleared
Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Radiology
94d
Cleared
Feb 04, 2022
Magnifico Open, Magnifico MSK
Esaote, S.P.A.
Radiology
184d
Cleared
Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
58d
Cleared
Nov 19, 2021
MR 5300
Philips Medical Systems Nederland B.V.
Radiology
87d
Cleared
Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
34d
Cleared
Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
56d
Cleared
Jul 01, 2021
MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.
Radiology
122d
Cleared
May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
40d
Cleared
May 13, 2021
SIGNA 7.0T
Ge Medical Systems, LLC
Radiology
28d
Cleared
Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
55d
Cleared
Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Radiology
128d
Cleared
Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
Canon Medical Systems Corporation
Radiology
48d
Cleared
Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
112d
Cleared
Mar 02, 2021
MRI PPG Patient Cable
Ivy Biomedical Systems, Inc.
Radiology
77d
Cleared
Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
60d
Cleared
Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Radiology
116d