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
193–216 of 1101
Cleared Jul 01, 2019
MRopen 0.5 T
K190524
Asg Superconductors S.P.A.
Radiology · 119d
Cleared Jun 27, 2019
LiverMultiScan (LMSv3)
K190017
Perspectum Diagnostics, Ltd.
Radiology · 175d
Cleared Jun 26, 2019
Vantage Titan 3T, MRT-3010, V2.5
K191128
Canon Medical Systems Corporation
Radiology · 58d
Cleared Jun 13, 2019
SyMRI
K191036
Syntheticmr AB
Radiology · 56d
Cleared Jun 04, 2019
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
K190461
Philips Medical Systems Nederland B.V.
Radiology · 98d
Cleared May 31, 2019
MAGNETOM Avanto Fit
K190757
Siemens Medical Solution USA, Inc.
Radiology · 67d
Cleared May 29, 2019
uMR 780, uMR 790
K191157
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 28d
Cleared Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
K183657
Canon Medical Systems Corporation
Radiology · 78d
Cleared Feb 22, 2019
EMMA 1.5T MRI System
K183621
Time Medical Limited
Radiology · 58d
Cleared Feb 15, 2019
MAGNETOM Terra
K183222
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 15, 2019
MAGNETOM Aera
K190138
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Feb 14, 2019
MyoStrain 5.1
K182756
Myocardial Solutions
Radiology · 139d
Cleared Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K183063
Philips Medical Systems Nederland B.V.
Radiology · 101d
Cleared Feb 14, 2019
MAGNETOM Amira, MAGNETOM Sempra
K183221
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Jan 24, 2019
MAGNETOM Lumina
K183244
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Jan 22, 2019
O-Scan
K183685
Esaote, S.P.A.
Radiology · 25d
Cleared Jan 18, 2019
SIGNA Premier
K183231
Ge Medical Systems, LLC
Radiology · 59d
Cleared Jan 18, 2019
Magnetom Vida
K183254
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 59d
Cleared Dec 06, 2018
AMRA Profiler
K173749
Amra Medical AB
Radiology · 363d
Cleared Nov 06, 2018
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
K181613
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 26, 2018
MAGNETOM Aera
K182299
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Oct 19, 2018
MAGNETOM Vida
K181433
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
K182282
Canon Medical Systems Corporation
Radiology · 57d