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
Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
202d
Cleared
Aug 02, 2023
Ingenia Elition R5.7.1 SP4 MR Systems
Philips Medical Systems Nederland B.V.
Radiology
26d
Cleared
May 23, 2023
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
124d
Cleared
May 18, 2023
uMR 570
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
59d
Cleared
Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
Philips Medical Systems Nederland B.V.
Radiology
23d
Cleared
Apr 06, 2023
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland B.V.
Radiology
141d
Cleared
Mar 28, 2023
MAGNETOM Amira
Siemens Medical Solutions USA, Inc.
Radiology
147d
Cleared
Mar 02, 2023
1.5T 24E Posterior Array
Shenzhen RF Tech Co., Ltd.
Radiology
139d
Cleared
Feb 24, 2023
MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
Radiology
445d
Cleared
Feb 22, 2023
Swoop® Portable MR Imaging System™
Hyperfine, 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
Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
23d
Cleared
Jun 24, 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Radiology
116d
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
Cleared
Apr 01, 2022
MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.
Radiology
72d
Cleared
Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
25d
Cleared
Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Philips Medical Systems Nederland B.V.
Radiology
120d
Cleared
Mar 03, 2022
MR Elastography
Canon Medical Systems Corporation
Radiology
57d