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
Mar 31, 2016
ECHELON Oval V 5.1 MRI System
Hitachi Medical Systems America, Inc.
Radiology
111d
Cleared
Mar 29, 2016
SIGNAPioneer
Ge Healthcare
Radiology
25d
Cleared
Jan 08, 2016
MRI Dynamic Analysis Plus
Esaote, S.P.A.
Radiology
81d
Cleared
Dec 24, 2015
MAGNETOM Amira
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Oct 27, 2015
SIGNA Pioneer
Ge Healthcare
Radiology
14d
Cleared
Oct 23, 2015
Vantage Titan 3T
Toshibamedical Systems Corporation
Radiology
63d
Cleared
Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.
Radiology
110d
Cleared
Sep 08, 2015
S-scan
Esaote, S.P.A.
Radiology
81d
Cleared
Jul 29, 2015
ECHELON Oval V 5.0 MRI System
Hitachi Medical Systems America, Inc.
Radiology
104d
Cleared
Apr 17, 2015
Vantage Titan 1.5T, V3.1, MRT-1510
Toshibamedical Systems Corporation
Radiology
57d
Cleared
Apr 09, 2015
G-scan Brio
Esaote, S.P.A.
Radiology
224d
Cleared
Apr 09, 2015
Vantage Titan 3T
Toshibamedical Systems Corporation
Radiology
171d
Cleared
Apr 09, 2015
O-MAR
Philips Medical Systems Nederland B.V.
Radiology
147d
Cleared
Mar 02, 2015
TRILLIUM Oval MR System
Hitachi Medical Systems America, Inc.
Radiology
160d
Cleared
Dec 05, 2014
Discovery MR750 3.0T
Ge Medical Systems, LLC
Radiology
102d
Cleared
Nov 19, 2014
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
Siemens Medical Solutions USA, Inc.
Radiology
121d
Cleared
Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
Siemens Medical Solutions USA, Inc.
Radiology
30d
Cleared
Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
Ge Medical Systems, LLC
Radiology
57d
Cleared
Sep 19, 2014
VANTAGE ELAN
Toshiba America Medical Systems, In.C
Radiology
108d
Cleared
Jun 13, 2014
MR ELASTOGRAPHY
Philips Medical Systems Nederland B.V.
Radiology
87d
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 12, 2014
MDIXON-QUANT
Philips Medical Systems Nederland B.V.
Radiology
89d
Cleared
Dec 30, 2013
G-SCAN BRIO
Esaote, S.P.A.
Radiology
47d
Cleared
Dec 13, 2013
S-SCAN
Esaote, S.P.A.
Radiology
168d