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
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
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
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 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
Dec 13, 2012
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
Toshiba America Medical Systems, In.C
Radiology
108d
Cleared
Dec 11, 2012
MAVRIC SL
Ge Medical Systems, LLC
Radiology
391d
Cleared
Nov 13, 2012
OPTIMA MR 430S
Ge Medical Systems, LLC
Radiology
43d
Cleared
Sep 20, 2012
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
Ge Medical Systems, LLC
Radiology
105d
Cleared
Aug 06, 2012
G-SCAN BRIO
Esaote, S.P.A.
Radiology
28d
Cleared
Jul 16, 2012
MAGNETOM SPECTRA
Siemens Medical Solutions USA, Inc.
Radiology
91d
Cleared
Jul 09, 2012
S-SCAN
Esaote, S.P.A.
Radiology
34d
Cleared
Jun 01, 2012
VANTAGE TITAN
Toshibamedical Systems Corporation
Radiology
92d
Cleared
May 23, 2012
VANTAGE TITAN 3T
Toshibamedical Systems Corporation
Radiology
96d
Cleared
May 01, 2012
ECHELON OVAL MRI SYSTEM
Hitachi Medical Systems America, Inc.
Radiology
189d
Cleared
May 01, 2012
SPEEDUP SOFTWARE OPTION
Esaote, S.P.A.
Radiology
50d
Cleared
Jan 13, 2012
VANTAGE TITAN 3T
Toshibamedical Systems Corporation
Radiology
86d
Cleared
Jan 13, 2012
OPTIMA MR450W
Ge Medical Systems, LLC
Radiology
51d