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
265–288 of 1101
Cleared Mar 31, 2016
ECHELON Oval V 5.1 MRI System
K153547
Hitachi Medical Systems America, Inc.
Radiology · 111d
Cleared Mar 29, 2016
SIGNAPioneer
K160621
Ge Healthcare
Radiology · 25d
Cleared Jan 08, 2016
MRI Dynamic Analysis Plus
K153039
Esaote, S.P.A.
Radiology · 81d
Cleared Dec 24, 2015
MAGNETOM Amira
K152283
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Oct 27, 2015
SIGNA Pioneer
K153003
Ge Healthcare
Radiology · 14d
Cleared Oct 23, 2015
Vantage Titan 3T
K152371
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
K151579
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 08, 2015
S-scan
K151668
Esaote, S.P.A.
Radiology · 81d
Cleared Jul 29, 2015
ECHELON Oval V 5.0 MRI System
K151015
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Apr 17, 2015
Vantage Titan 1.5T, V3.1, MRT-1510
K150427
Toshibamedical Systems Corporation
Radiology · 57d
Cleared Apr 09, 2015
G-scan Brio
K142421
Esaote, S.P.A.
Radiology · 224d
Cleared Apr 09, 2015
Vantage Titan 3T
K143008
Toshibamedical Systems Corporation
Radiology · 171d
Cleared Apr 09, 2015
O-MAR
K143253
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Dec 05, 2014
Discovery MR750 3.0T
K142361
Ge Medical Systems, LLC
Radiology · 102d
Cleared Nov 19, 2014
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
K141977
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
K142515
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
K142085
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 19, 2014
VANTAGE ELAN
K141472
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Jun 13, 2014
MR ELASTOGRAPHY
K140666
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
K140253
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Feb 12, 2014
MDIXON-QUANT
K133526
Philips Medical Systems Nederland B.V.
Radiology · 89d
Cleared Dec 30, 2013
G-SCAN BRIO
K133490
Esaote, S.P.A.
Radiology · 47d
Cleared Dec 13, 2013
S-SCAN
K131996
Esaote, S.P.A.
Radiology · 168d