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
Jul 17, 2025
uMR Ultra
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
244d
Cleared
Jul 16, 2025
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
258d
Cleared
Jul 11, 2025
Achieva
Philips Medical Systems Nederland B.V.
Radiology
29d
Cleared
Jun 16, 2025
MAGNETOM Flow.Ace
Siemens Shenzhen Magnetic Resonance , Ltd.
Radiology
122d
Cleared
Jun 16, 2025
MAGNETOM Avanto Fit
Siemens Healthcare GmbH
Radiology
122d
Cleared
Jun 05, 2025
Sonic DL
Ge Medical Systems, LLC
Radiology
190d
Cleared
Jun 04, 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V.
Radiology
29d
Cleared
May 30, 2025
Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
Radiology
123d
Cleared
May 21, 2025
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
233d
Cleared
May 21, 2025
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Radiology
27d
Cleared
Mar 17, 2025
SIGNA Prime Elite
Ge Medical Systems, LLC
Radiology
34d
Cleared
Feb 12, 2025
SureWave Elastography (Q7000225)
Quality Electrodynamics, LLC
Radiology
218d
Cleared
Jan 17, 2025
Prenuvo Body Composition
Prenuvo
Radiology
121d
Cleared
Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
75d
Cleared
Dec 23, 2024
NIDO Baby Magnetic Resonance Imaging System
Jiangsu Lici Medical Device Co., Ltd.
Radiology
116d
Cleared
Dec 06, 2024
SyMRI
Syntheticmr AB (Publ.)
Radiology
105d
Cleared
Nov 26, 2024
MROpen Evo (03-2000-00)
Asg Superconductors S.P.A.
Radiology
118d
Cleared
Oct 17, 2024
SIGNA MAGNUS
Ge Medical Systems, LLC
Radiology
167d
Cleared
Oct 02, 2024
VitruvianScan (v1.0)
Perspectum, Ltd.
Radiology
93d
Cleared
Oct 01, 2024
MuscleView
Springbok, Inc.
Radiology
144d
Cleared
Aug 26, 2024
MyoStrain (6.0)
Myocardial Solutions, Inc.
Radiology
83d
Cleared
Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
84d
Cleared
Aug 13, 2024
ECHELON Synergy MRI System
Fujifilm Healthcare Corporation
Radiology
84d
Cleared
Jul 22, 2024
neo315
Neoscan Solution GmbH
Radiology
458d