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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
289–312 of 1101
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
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 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 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 Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
K122613
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Dec 11, 2012
MAVRIC SL
K113394
Ge Medical Systems, LLC
Radiology · 391d
Cleared Nov 13, 2012
OPTIMA MR 430S
K123068
Ge Medical Systems, LLC
Radiology · 43d
Cleared Sep 20, 2012
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
K121676
Ge Medical Systems, LLC
Radiology · 105d
Cleared Aug 06, 2012
G-SCAN BRIO
K122006
Esaote, S.P.A.
Radiology · 28d
Cleared Jul 16, 2012
MAGNETOM SPECTRA
K121160
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 09, 2012
S-SCAN
K121650
Esaote, S.P.A.
Radiology · 34d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638
Toshibamedical Systems Corporation
Radiology · 92d
Cleared May 23, 2012
VANTAGE TITAN 3T
K120487
Toshibamedical Systems Corporation
Radiology · 96d
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 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