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
Apr 04, 2014
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
Clearmri Solutions, Inc.
Radiology
247d
Cleared
Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
Siemens Medical Solutions USA, Inc.
Radiology
48d
Cleared
Feb 28, 2014
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
Suzhou Anke Medical System Co., Ltd.
Radiology
248d
Cleared
Feb 12, 2014
MDIXON-QUANT
Philips Medical Systems Nederland B.V.
Radiology
89d
Cleared
Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
Imris, Inc.
Radiology
70d
Cleared
Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
Aspect Imaging, Ltd.
Radiology
307d
Cleared
Dec 30, 2013
G-SCAN BRIO
Esaote, S.P.A.
Radiology
47d
Cleared
Dec 13, 2013
HEPAFAT SCAN
Resonance Health Analysis Services Pty, Ltd.
Radiology
520d
Cleared
Dec 13, 2013
S-SCAN
Esaote, S.P.A.
Radiology
168d
Cleared
Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
Siemens Medical Solutions USA, Inc.
Radiology
34d
Cleared
Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
Siemens Medical Solutions USA, Inc.
Radiology
136d
Cleared
Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
Ge Healthcare (Ge Medical Systems, LLC)
Radiology
108d
Cleared
Nov 15, 2013
MAGNETOM AERA
Siemens Medical Solutions USA, Inc.
Radiology
57d
Cleared
Nov 01, 2013
QUIET/SILENT SCANNING SUITE
Siemens Medical Solutions USA, Inc.
Radiology
52d
Cleared
Oct 16, 2013
VANTAGE TITAN 3T
Toshibamedical Systems Corporation
Radiology
96d
Cleared
Aug 30, 2013
SWIP
Philips Medical Systems Nederland B.V.
Radiology
121d
Cleared
Jul 19, 2013
ELIXBO PM545
Xbo Medical Systems Co., Ltd.
Radiology
129d
Cleared
May 23, 2013
DISCOVERY MR750W 3.0T
Ge Medical Systems, LLC
Radiology
127d
Cleared
May 17, 2013
MAGNETOM SKYRA
Siemens Medical Solutions USA, Inc.
Radiology
185d
Cleared
May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Mar 13, 2013
OPTIMA MR450W
Ge Healthcare (Ge Medical Systems, LLC)
Radiology
118d
Cleared
Mar 01, 2013
MAGNETOM ESSENZA WITH SYNGO MR D14
Siemens Medical Solutions USA, Inc.
Radiology
28d
Cleared
Feb 12, 2013
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN
Siemens Medical Solutions USA, Inc.
Radiology
54d
Cleared
Feb 07, 2013
M2 WRIST MRI SYSTEM
Aspect Imaging, Ltd.
Radiology
337d