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
Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Radiology
94d
Cleared
Feb 11, 2022
SIGNA Artist Evo
Ge Healthcare (Tianjin) Company Limited
Radiology
88d
Cleared
Feb 04, 2022
smart-sync
Northh Medical GmbH
Radiology
199d
Cleared
Feb 04, 2022
Magnifico Open, Magnifico MSK
Esaote, S.P.A.
Radiology
184d
Cleared
Jan 20, 2022
SIGNA Hero
Ge Healthcare (Ge Medical Systems, LLC)
Radiology
59d
Cleared
Jan 16, 2022
SIGNA Prime
Ge Healthcare (Tianjin) Company Limited
Radiology
205d
Cleared
Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
58d
Cleared
Nov 24, 2021
AMRA Profiler
Amra Medical AB
Radiology
152d
Cleared
Nov 19, 2021
MR 5300
Philips Medical Systems Nederland B.V.
Radiology
87d
Cleared
Nov 17, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Radiology
104d
Cleared
Nov 03, 2021
SyMRI
Syntheticmr AB
Radiology
352d
Cleared
Oct 07, 2021
OASIS MRI System
Hitachi Healthcare Americas
Radiology
154d
Cleared
Oct 05, 2021
RTHawk, HeartVista Cardiac Package
Heartvista, Inc.
Radiology
81d
Cleared
Aug 23, 2021
IMRIS iMRI 3T V
Deerfield Imaging, Inc.
Radiology
24d
Cleared
Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
34d
Cleared
Jul 22, 2021
QSM software, QSMetric
Medimagemetric, LLC
Radiology
161d
Cleared
Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
56d
Cleared
Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Radiology
26d
Cleared
Jul 01, 2021
MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.
Radiology
122d
Cleared
Jun 29, 2021
STAGE
Spintech, Inc.
Radiology
99d
Cleared
May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
40d
Cleared
May 13, 2021
SIGNA 7.0T
Ge Medical Systems, LLC
Radiology
28d
Cleared
Apr 28, 2021
TCL3 Motion Tracking System
Tracinnovations Aps
Radiology
156d
Cleared
Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Radiology
55d