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..
1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
Cleared
Dec 24, 2015
MAGNETOM Amira
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Dec 22, 2015
Magnetic Reasonance Imaging System
Jiangsu Magspin Instrument Co.,Ltd
Radiology
244d
Cleared
Oct 27, 2015
SIGNA Pioneer
Ge Healthcare
Radiology
14d
Cleared
Oct 23, 2015
Vantage Titan 3T
Toshibamedical Systems Corporation
Radiology
63d
Cleared
Oct 15, 2015
MrOpen
Paramed S.R.L.
Radiology
136d
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
Jul 10, 2015
SIGNA Pioneer
Ge Healthcare Japan Corporation
Radiology
231d
Cleared
Jun 23, 2015
LiverMultiScan
Mirada Medical, Ltd.
Radiology
246d
Cleared
May 08, 2015
MultiBand SENSE
Philips Medical Systems Nethrlands BV
Radiology
140d
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 20, 2015
mDIXON XD
Philips Medical Systems Nederlands B.V.
Radiology
141d
Cleared
Mar 02, 2015
TRILLIUM Oval MR System
Hitachi Medical Systems America, Inc.
Radiology
160d
Cleared
Feb 04, 2015
SIGNA Creator, SIGNA Explorer
Ge Healthcare (Ge Medical Systems, LLC)
Radiology
84d
Cleared
Feb 03, 2015
ECHOSTAR COMFORT 1.5T MRI
Alltech Medical Systems America, Inc.
Radiology
201d
Cleared
Dec 17, 2014
RTHawk, HeartVista Workstation with RTHawk
Heartvista, Inc.
Radiology
68d
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 23, 2014
SUPERNOVA C5 MRI SYSTEM
Liaoning Kampo Medical System Co., Ltd.
Radiology
497d
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