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..
1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
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
Cleared
Jul 16, 2024
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Radiology
102d
Cleared
Jun 26, 2024
Magnifico Open (100009900)
Esaote, S.P.A.
Radiology
63d
Cleared
May 10, 2024
APERTO Lucent MRI System
Fujifilm Healthcare Americas Corporation
Radiology
179d
Cleared
May 03, 2024
ECHELON Synergy V10.0
Fujifilm Healthcare Americas Corporation
Radiology
168d
Cleared
Apr 26, 2024
uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
162d
Cleared
Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
74d
Cleared
Apr 12, 2024
OASIS MRI System
Fujifilm Healthcare Corporation
Radiology
43d
Cleared
Apr 10, 2024
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
23d
Cleared
Mar 29, 2024
MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Radiology
25d
Cleared
Mar 26, 2024
SyMRI
Syntheticmr AB (Publ.)
Radiology
126d
Cleared
Mar 22, 2024
MAGNETOM Terra
Siemens Medical Solutions USA, Inc.
Radiology
232d
Cleared
Mar 22, 2024
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Radiology
25d