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..
1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
Cleared
Feb 21, 2023
NEONA 1.5T MRI System
Time Medical Limited
Radiology
208d
Cleared
Feb 16, 2023
uMR 680
Shanghai United Imaging Intelligence Co., Ltd.
Radiology
157d
Cleared
Feb 13, 2023
SIGNA Victor
Ge Healthcare (Tianjin) Company Limited
Radiology
91d
Cleared
Jan 26, 2023
ECHELON Oval V6.2 MRI System
Fujifilm Healthcare Corporation
Radiology
237d
Cleared
Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.
Radiology
39d
Cleared
Dec 06, 2022
Swoop Portable MR Imaging System
Hyperfine, Inc.
Radiology
46d
Cleared
Oct 28, 2022
Stage
Spintech, Inc.
Radiology
28d
Cleared
Oct 27, 2022
uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
265d
Cleared
Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
28d
Cleared
Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
Radiology
90d
Cleared
Sep 06, 2022
LiverMultiScan v5 (LMSv5)
Perspectum
Radiology
263d
Cleared
Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
23d
Cleared
Aug 29, 2022
TCL3 Motion Tracking System
Tracinnovations A/S
Radiology
69d
Cleared
Jul 28, 2022
Swoop Portable MR Imaging System
Hyperfine, Inc.
Radiology
27d
Cleared
Jul 12, 2022
Veuron-Brain-mN1
Heuron Co., Ltd.
Radiology
613d
Cleared
Jul 01, 2022
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Radiology
86d
Cleared
Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Radiology
116d
Cleared
Jun 10, 2022
Swoop Portable MR Imaging System
Hyperfine, Inc.
Radiology
28d
Cleared
Jun 08, 2022
AIR Recon DL
Ge Medical Systems,Llc (Ge Healthcare)
Radiology
196d
Cleared
May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Radiology
185d
Cleared
May 13, 2022
MAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc.
Radiology
73d
Cleared
Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Radiology
29d
Cleared
Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
74d
Cleared
Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
57d