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