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
313–336 of 1104
Cleared Apr 04, 2014
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
K132381
Clearmri Solutions, Inc.
Radiology · 247d
Cleared Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
K140253
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Feb 28, 2014
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
K131896
Suzhou Anke Medical System Co., Ltd.
Radiology · 248d
Cleared Feb 12, 2014
MDIXON-QUANT
K133526
Philips Medical Systems Nederland B.V.
Radiology · 89d
Cleared Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
K133692
Imris, Inc.
Radiology · 70d
Cleared Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
K130692
Aspect Imaging, Ltd.
Radiology · 307d
Cleared Dec 30, 2013
G-SCAN BRIO
K133490
Esaote, S.P.A.
Radiology · 47d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035
Resonance Health Analysis Services Pty, Ltd.
Radiology · 520d
Cleared Dec 13, 2013
S-SCAN
K131996
Esaote, S.P.A.
Radiology · 168d
Cleared Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119
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
K132376
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Nov 15, 2013
MAGNETOM AERA
K132951
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Nov 01, 2013
QUIET/SILENT SCANNING SUITE
K132831
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Oct 16, 2013
VANTAGE TITAN 3T
K132160
Toshibamedical Systems Corporation
Radiology · 96d
Cleared Aug 30, 2013
SWIP
K131241
Philips Medical Systems Nederland B.V.
Radiology · 121d
Cleared Jul 19, 2013
ELIXBO PM545
K130658
Xbo Medical Systems Co., Ltd.
Radiology · 129d
Cleared May 23, 2013
DISCOVERY MR750W 3.0T
K130115
Ge Medical Systems, LLC
Radiology · 127d
Cleared May 17, 2013
MAGNETOM SKYRA
K123510
Siemens Medical Solutions USA, Inc.
Radiology · 185d
Cleared May 17, 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Mar 13, 2013
OPTIMA MR450W
K123522
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 118d
Cleared Mar 01, 2013
MAGNETOM ESSENZA WITH SYNGO MR D14
K130262
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
K123938
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701
Aspect Imaging, Ltd.
Radiology · 337d