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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
241–264 of 1104
Cleared Jan 26, 2018
Vantage Galan 3T, V4.6
K173382
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Jan 26, 2018
SyMRI
K173558
Syntheticmr AB
Radiology · 70d
Cleared Jan 22, 2018
3D APT
K172920
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Jan 11, 2018
ECHELON OVAL V6.0A MRI System
K172110
Hitachi Healthcare Americas Corporation
Radiology · 182d
Cleared Dec 19, 2017
MAGNETOM Amira
K173600
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 21, 2017
LiverMultiScan
K172685
Perspectum Diagnostics, Ltd.
Radiology · 76d
Cleared Nov 17, 2017
Vantage Titan 3T, MRT-3010/A7, M-Power GX
K172878
Toshiba Medical Systems Corporation, Japan
Radiology · 57d
Cleared Oct 12, 2017
MAGNETOM Terra
K170840
Siemens Medical Solutions USA, Inc.
Radiology · 205d
Cleared Aug 29, 2017
SyMRI
K162943
Syntheticmr AB
Radiology · 312d
Cleared Jul 21, 2017
Vantage Elan 1.5T, V4.0
K171597
Toshibamedical Systems Corporation
Radiology · 51d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978
Aspect Imaging, Ltd.
Radiology · 107d
Cleared Jul 14, 2017
RTHawk, HeartVista Cardiac Package
K170090
Heartvista, Inc.
Radiology · 185d
Cleared Jul 14, 2017
SIGNA Premier
K171128
Ge Medical Systems, LLC
Radiology · 88d
Cleared Jun 14, 2017
MAGNETOM Vida
K170396
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jun 07, 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
K170412
Toshibamedical Systems Corporation
Radiology · 117d
Cleared Apr 20, 2017
HyperSense
K162722
Ge Medical Systems, LLC
Radiology · 203d
Cleared Apr 10, 2017
Comfort EC710
K163192
Alltech Medical Systems America, Inc.
Radiology · 146d
Cleared Mar 17, 2017
Discovery MR750 3.0T
K163331
Ge Medical Systems, LLC
Radiology · 109d
Cleared Jan 27, 2017
MAGNETOM Sempra with syngo MR E11S
K163211
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Jan 27, 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
K163312
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931
Philips Medical Systems Nederland B.V.
Radiology · 79d
Cleared Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
K163116
Philips Medical Systems Nederland B.V.
Radiology · 60d
Cleared Dec 30, 2016
MultiBand SENSE
K162940
Philips Medical Systems Nederland B.V.
Radiology · 70d
Cleared Nov 25, 2016
Vantage Galan 3T, MRT-3020, V4.0
K162183
Toshibamedical Systems Corporation
Radiology · 113d