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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
361–384 of 1110
Cleared May 01, 2012
ECHELON OVAL MRI SYSTEM
K113145
Hitachi Medical Systems America, Inc.
Radiology · 189d
Cleared May 01, 2012
SPEEDUP SOFTWARE OPTION
K120748
Esaote, S.P.A.
Radiology · 50d
Cleared Mar 27, 2012
BRIVO MR355
K120778
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 13d
Cleared Jan 13, 2012
VANTAGE TITAN 3T
K113093
Toshibamedical Systems Corporation
Radiology · 86d
Cleared Jan 13, 2012
OPTIMA MR450W
K113490
Ge Medical Systems, LLC
Radiology · 51d
Cleared Dec 30, 2011
VISIA DYNAMIC REVIEW
K113337
Mevis Medical Solutions AG
Radiology · 46d
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 Aug 02, 2011
VANTAGE TITAN 3T
K102489
Toshiba Medical Systems Corporation, Japan
Radiology · 336d
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 05, 2010
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
K101813
Imris, Inc.
Radiology · 98d
Cleared Oct 01, 2010
MAGNETOM AERA
K101347
Siemens Medical Solutions USA, Inc.
Radiology · 141d