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 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
Cleared
Feb 29, 2024
MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
Radiology
174d
Cleared
Feb 15, 2024
InVision™ 1.5 Surgical Theatre
Deerfield Imaging, Inc.
Radiology
27d
Cleared
Feb 08, 2024
neuro42 MRI System
Neuro42, Inc.
Radiology
162d
Cleared
Jan 19, 2024
SIGNA Champion
Ge Healthcare (Tianjin) Company Limited
Radiology
59d
Cleared
Dec 22, 2023
MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Radiology
123d
Cleared
Dec 18, 2023
MAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.
Radiology
201d
Cleared
Nov 14, 2023
MAGNETOM Avanto fit
Siemens Medical Solutions USA, Inc.
Radiology
89d
Cleared
Nov 09, 2023
MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.
Radiology
160d
Cleared
Oct 27, 2023
Digital Expert Access with Remote Scanning
Ge Healthcare
Radiology
84d
Cleared
Oct 23, 2023
MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
Radiology
146d
Cleared
Oct 06, 2023
Swoop® Portable MR Imaging System®
Hyperfine, Inc.
Radiology
28d
Cleared
Sep 06, 2023
MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Radiology
21d