LNH · Class II · 21 CFR 892.1000

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
121–144 of 1101
Cleared Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
K213693
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Feb 04, 2022
smart-sync
K212271
Northh Medical GmbH
Radiology · 199d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419
Esaote, S.P.A.
Radiology · 184d
Cleared Jan 20, 2022
SIGNA Hero
K213668
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 16, 2022
SIGNA Prime
K211980
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
K213305
Canon Medical Systems Corporation
Radiology · 58d
Cleared Nov 24, 2021
AMRA Profiler
K211983
Amra Medical AB
Radiology · 152d
Cleared Nov 19, 2021
MR 5300
K212673
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Nov 17, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K212456
Hyperfine, Inc.
Radiology · 104d
Cleared Nov 03, 2021
SyMRI
K203372
Syntheticmr AB
Radiology · 352d
Cleared Oct 07, 2021
OASIS MRI System
K211406
Hitachi Healthcare Americas
Radiology · 154d
Cleared Oct 05, 2021
RTHawk, HeartVista Cardiac Package
K212233
Heartvista, Inc.
Radiology · 81d
Cleared Aug 23, 2021
IMRIS iMRI 3T V
K212367
Deerfield Imaging, Inc.
Radiology · 24d
Cleared Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K212056
Canon Medical Systems Corporation
Radiology · 34d
Cleared Jul 22, 2021
QSM software, QSMetric
K210415
Medimagemetric, LLC
Radiology · 161d
Cleared Jul 22, 2021
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
K211633
Canon Medical Systems Corporation
Radiology · 56d
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818
Hyperfine, Inc.
Radiology · 26d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Jun 29, 2021
STAGE
K210843
Spintech, Inc.
Radiology · 99d
Cleared May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K211037
Canon Medical Systems Corporation
Radiology · 40d
Cleared May 13, 2021
SIGNA 7.0T
K211118
Ge Medical Systems, LLC
Radiology · 28d
Cleared Apr 28, 2021
TCL3 Motion Tracking System
K203451
Tracinnovations Aps
Radiology · 156d
Cleared Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K210340
Canon Medical Systems Corporation
Radiology · 55d