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 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
97–120 of 1098
Cleared Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
K213693
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419
Esaote, S.P.A.
Radiology · 184d
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 19, 2021
MR 5300
K212673
Philips Medical Systems Nederland B.V.
Radiology · 87d
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
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
K211633
Canon Medical Systems Corporation
Radiology · 56d
Cleared Jul 01, 2021
MAGNETOM Free.Max
K210611
Siemens Medical Solutions USA, Inc.
Radiology · 122d
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 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K210340
Canon Medical Systems Corporation
Radiology · 55d
Cleared Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
K203443
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
K210164
Canon Medical Systems Corporation
Radiology · 48d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323
Canon Medical Systems Corporation
Radiology · 112d
Cleared Mar 02, 2021
MRI PPG Patient Cable
K203653
Ivy Biomedical Systems, Inc.
Radiology · 77d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553
Canon Medical Systems Corporation
Radiology · 60d
Cleared Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
K202767
Canon Medical Systems Corporation
Radiology · 116d