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
361–384 of 1104
Cleared Dec 02, 2011
VANTAGE TITAN HSR
K112003
Toshibamedical Systems Corporation
Radiology · 142d
Cleared Nov 23, 2011
MAGNETOM AERA AND MAGNETOM SKYRA
K111242
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327
Ge Healthcare Japan Corporation
Radiology · 322d
Cleared Jul 26, 2011
PICA WHOLE-BODY MRI SYSTEM
K110942
Time Medical Limited
Radiology · 113d
Cleared Jul 15, 2011
G-SCAN
K111803
Esaote, S.P.A.
Radiology · 18d
Cleared Jul 01, 2011
ENDOSCOUT TRACKING SYSTEM
K111226
Robin Medical, Inc.
Radiology · 60d
Cleared Jun 28, 2011
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
K111340
Medtec, Inc.
Radiology · 47d
Cleared Apr 08, 2011
A-CHANNELS LUMBAT SPINE COILS 17
K110802
Esaote, S.P.A.
Radiology · 16d
Cleared Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
K103411
GE Medical Systems
Radiology · 120d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151
Philips Health Care
Radiology · 63d
Cleared Feb 17, 2011
G-SCAN
K110238
Esaote, S.P.A.
Radiology · 22d
Cleared Feb 11, 2011
1.5T OPTIMA MR430S
K103238
Ge Medical Systems, LLC
Radiology · 101d
Cleared Feb 11, 2011
BRIVO MR355, OPTIMA MR360
K103330
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 91d
Cleared Feb 08, 2011
MEDICAL VISORS MV100
K103507
Medical Visors, Inc.
Radiology · 71d
Cleared Nov 09, 2010
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344
Philips Medical Systems Nederland B.V.
Radiology · 83d
Cleared Oct 01, 2010
MAGNETOM AERA
K101347
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
K102155
Ge Medical Systems, LLC
Radiology · 32d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738
Medtec, Inc.
Radiology · 161d
Cleared Jan 06, 2010
3D ASL
K092925
Ge Medical Systems, LLC
Radiology · 105d
Cleared Dec 23, 2009
O-SCAN MR SYSTEM
K092469
Esaote, S.P.A.
Radiology · 134d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237
Neusoft Medical Systems Co., Ltd.
Radiology · 48d
Cleared Jul 24, 2009
MR-TOUCH OPTION
K083421
Ge Medical Systems, LLC
Radiology · 247d
Cleared Jul 17, 2009
OPTIMA MR450W
K091536
Ge Medical Systems, LLC
Radiology · 52d
Cleared Apr 28, 2009
SYNGO BREVIS
K090038
Siemens Medical Solutions USA, Inc.
Radiology · 112d