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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
409–432 of 1110
Cleared Mar 09, 2009
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
K082964
Prism Clinical Imaging, Inc.
Radiology · 157d
Cleared Feb 17, 2009
ECHELON C MRI SYSTEM
K083533
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Dec 16, 2008
NEURO III-SV
K083137
Imris, Inc.
Radiology · 54d
Cleared Nov 07, 2008
SYNGO MR B17
K082427
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Nov 04, 2008
DISCOVERY MR450
K083147
Ge Medical Systems, LLC
Radiology · 11d
Cleared Oct 01, 2008
MAGNETOM C!
K082331
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Sep 16, 2008
MODIFICATION TO AURORA MRI SYSTEM
K073425
Aurora Imaging Technology, Inc.
Radiology · 288d
Cleared Sep 09, 2008
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
K082485
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
K082100
Alltech Medical Systems America, Inc.
Radiology · 12d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916
Ge Medical Systems, LLC
Radiology · 15d
Cleared May 23, 2008
MROPEN
K073362
Paramed S.R.L.
Radiology · 175d
Cleared May 16, 2008
FMRI HARDWARE SYSTEM
K080515
Nordicneurolab
Radiology · 81d
Cleared May 15, 2008
IB NEURO, VERSION 1.0
K080762
Imaging Biometrics, LLC
Radiology · 58d
Cleared Apr 29, 2008
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
K080968
Esaote, S.P.A.
Radiology · 25d
Cleared Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
K081028
Ge Medical Systems, LLC
Radiology · 14d
Cleared Mar 10, 2008
MRJ EXTENDED
K080098
Paramed S.R.L.
Radiology · 56d
Cleared Mar 04, 2008
QPLAQUE MR
K073156
Medis Medical Imaging Systems BV
Radiology · 117d
Cleared Feb 06, 2008
MSK EXTREME MR SCANNER, MODEL AA5000
K080048
Oni Medical Systems, Inc.
Radiology · 29d
Cleared Feb 01, 2008
MSTAR MPD4500
K073457
Xinaomdt Technology Co., Ltd.
Radiology · 53d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167
Ge Medical Systems, LLC
Radiology · 56d
Cleared Dec 10, 2007
CHASE MR SYSTEM
K072473
Chase Medical, LP
Radiology · 97d
Cleared Nov 21, 2007
MRI SYSTEM, MODEL MAGFINDER II / AI 3200
K072850
Advanced Imaging Laboratory
Radiology · 48d
Cleared Nov 21, 2007
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081
Toshiba America Medical Systems, In.C
Radiology · 20d