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..
1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
Cleared
Oct 23, 2023
MAGNETOM Vida
Siemens Medical Solutions USA, Inc.
Radiology
146d
Cleared
Oct 11, 2023
Synq Software Version 1.3
Synaptive Medical, Inc.
Radiology
20d
Cleared
Oct 06, 2023
Swoop® Portable MR Imaging System®
Hyperfine, Inc.
Radiology
28d
Cleared
Sep 29, 2023
Terran NM-101
Terran Biosciences, Inc.
Radiology
249d
Cleared
Sep 06, 2023
MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Radiology
21d
Cleared
Sep 05, 2023
Promaxo MRI System II
Promaxo, Inc.
Radiology
29d
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
Jul 13, 2023
ECHELON Synergy MRI system
Fujifilm Healthcare Corporation
Radiology
241d
Cleared
Jun 20, 2023
HepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty, Ltd.
Radiology
32d
Cleared
May 30, 2023
Sonic DL
Ge Medical Systems,Llc (Ge Healthcare)
Radiology
188d
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 20, 2023
MOBINEURO Alita Intraoperative MRI System
Sino Canada Health Engineering Research Institute (Hefei)
Radiology
87d
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
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