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
Nov 20, 2007
FMRI HARDWARE SYSTEM
Nordicneurolab
Radiology
18d
Cleared
Nov 15, 2007
CHOY COMPRESSION FRAME
Choy Medical Technologies, Inc.
Radiology
224d
Cleared
Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
Ge Medical Systems, LLC
Radiology
8d
Cleared
Oct 10, 2007
MAGNETOM VERIO
Siemens Medical Solutions USA, Inc.
Radiology
58d
Cleared
Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Hitachi Medical Systems America, Inc.
Radiology
36d
Cleared
Aug 14, 2007
MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc.
Radiology
33d
Cleared
May 22, 2007
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
Imris, Inc.
Radiology
33d
Cleared
May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
Neusoft Medical Systems Co., Ltd.
Radiology
15d
Cleared
Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
Philips Medical Systems
Radiology
38d
Cleared
Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
Toshiba America Medical Systems, In.C
Radiology
14d
Cleared
Nov 09, 2006
S-SCAN MRI SYSTEM
Esaote, S.P.A.
Radiology
17d
Cleared
Nov 03, 2006
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
Siemens Medi Cal Solutions, Inc.
Radiology
73d
Cleared
Oct 27, 2006
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
Neusoft Medical Systems Co., Ltd.
Radiology
32d
Cleared
Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Imris, Inc.
Radiology
36d
Cleared
Jul 28, 2006
DIAGNOSOFT HARP
Diagnosoft, Inc.
Radiology
73d
Cleared
Jul 28, 2006
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
Fonar Corp.
Radiology
21d
Cleared
Jul 25, 2006
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
Esaote, S.P.A.
Radiology
63d
Cleared
Jun 13, 2006
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
Kyron Clinical Imaging, Inc.
Radiology
40d
Cleared
May 24, 2006
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
Neusoft Medical Systems Co., Ltd.
Radiology
30d
Cleared
May 04, 2006
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
Esaote, S.P.A.
Radiology
27d
Cleared
Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
Hitachi Medical Systems America, Inc.
Radiology
57d
Cleared
Jan 18, 2006
EXCELART VANTAGE ZGV
Toshibamedical Systems Corporation
Radiology
15d
Cleared
Jan 13, 2006
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
Siemens Medi Cal Solutions, Inc.
Radiology
133d
Cleared
Dec 08, 2005
CADIMAS VERSION 1.0
Alan Penn & Associates., Inc.
Radiology
135d