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
385–408 of 1104
Cleared Feb 17, 2009
ECHELON C MRI SYSTEM
K083533
Hitachi Medical Systems America, Inc.
Radiology · 81d
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 09, 2008
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
K082485
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916
Ge Medical Systems, LLC
Radiology · 15d
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 04, 2008
QPLAQUE MR
K073156
Medis Medical Imaging Systems BV
Radiology · 117d
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
Cleared Nov 15, 2007
CHOY COMPRESSION FRAME
K070968
Choy Medical Technologies, Inc.
Radiology · 224d
Cleared Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998
Ge Medical Systems, LLC
Radiology · 8d
Cleared Oct 10, 2007
MAGNETOM VERIO
K072237
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Aug 14, 2007
MAGNETOM ESSENZA
K071925
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
K071099
Imris, Inc.
Radiology · 33d
Cleared May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
K071154
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559
Philips Medical Systems
Radiology · 38d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 09, 2006
S-SCAN MRI SYSTEM
K063207
Esaote, S.P.A.
Radiology · 17d