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
Cleared
Dec 02, 2011
VANTAGE TITAN HSR
Toshibamedical Systems Corporation
Radiology
142d
Cleared
Nov 23, 2011
MAGNETOM AERA AND MAGNETOM SKYRA
Siemens Medical Solutions USA, Inc.
Radiology
204d
Cleared
Sep 30, 2011
DISCOVERY MR750W 3.0T
Ge Healthcare Japan Corporation
Radiology
322d
Cleared
Jul 26, 2011
PICA WHOLE-BODY MRI SYSTEM
Time Medical Limited
Radiology
113d
Cleared
Jul 15, 2011
G-SCAN
Esaote, S.P.A.
Radiology
18d
Cleared
Jul 01, 2011
ENDOSCOUT TRACKING SYSTEM
Robin Medical, Inc.
Radiology
60d
Cleared
Jun 28, 2011
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
Medtec, Inc.
Radiology
47d
Cleared
Apr 08, 2011
A-CHANNELS LUMBAT SPINE COILS 17
Esaote, S.P.A.
Radiology
16d
Cleared
Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
GE Medical Systems
Radiology
120d
Cleared
Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Philips Health Care
Radiology
63d
Cleared
Feb 17, 2011
G-SCAN
Esaote, S.P.A.
Radiology
22d
Cleared
Feb 11, 2011
1.5T OPTIMA MR430S
Ge Medical Systems, LLC
Radiology
101d
Cleared
Feb 11, 2011
BRIVO MR355, OPTIMA MR360
Ge Hangwei Medical Systems Co., Ltd.
Radiology
91d
Cleared
Feb 08, 2011
MEDICAL VISORS MV100
Medical Visors, Inc.
Radiology
71d
Cleared
Nov 09, 2010
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
Philips Medical Systems Nederland B.V.
Radiology
83d
Cleared
Oct 01, 2010
MAGNETOM AERA
Siemens Medical Solutions USA, Inc.
Radiology
141d
Cleared
Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
Ge Medical Systems, LLC
Radiology
32d
Cleared
May 14, 2010
MRI PATIENT POSITIONING DEVICES
Medtec, Inc.
Radiology
161d
Cleared
Jan 06, 2010
3D ASL
Ge Medical Systems, LLC
Radiology
105d
Cleared
Dec 23, 2009
O-SCAN MR SYSTEM
Esaote, S.P.A.
Radiology
134d
Cleared
Sep 09, 2009
NSM-S15 SYSTEM
Neusoft Medical Systems Co., Ltd.
Radiology
48d
Cleared
Jul 24, 2009
MR-TOUCH OPTION
Ge Medical Systems, LLC
Radiology
247d
Cleared
Jul 17, 2009
OPTIMA MR450W
Ge Medical Systems, LLC
Radiology
52d
Cleared
Apr 28, 2009
SYNGO BREVIS
Siemens Medical Solutions USA, Inc.
Radiology
112d