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
289–312 of 1104
Cleared Sep 08, 2015
S-scan
K151668
Esaote, S.P.A.
Radiology · 81d
Cleared Jul 29, 2015
ECHELON Oval V 5.0 MRI System
K151015
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345
Ge Healthcare Japan Corporation
Radiology · 231d
Cleared Jun 23, 2015
LiverMultiScan
K143020
Mirada Medical, Ltd.
Radiology · 246d
Cleared May 08, 2015
MultiBand SENSE
K143606
Philips Medical Systems Nethrlands BV
Radiology · 140d
Cleared Apr 17, 2015
Vantage Titan 1.5T, V3.1, MRT-1510
K150427
Toshibamedical Systems Corporation
Radiology · 57d
Cleared Apr 09, 2015
G-scan Brio
K142421
Esaote, S.P.A.
Radiology · 224d
Cleared Apr 09, 2015
Vantage Titan 3T
K143008
Toshibamedical Systems Corporation
Radiology · 171d
Cleared Apr 09, 2015
O-MAR
K143253
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Mar 20, 2015
mDIXON XD
K143128
Philips Medical Systems Nederlands B.V.
Radiology · 141d
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Feb 04, 2015
SIGNA Creator, SIGNA Explorer
K143251
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 84d
Cleared Feb 03, 2015
ECHOSTAR COMFORT 1.5T MRI
K141945
Alltech Medical Systems America, Inc.
Radiology · 201d
Cleared Dec 17, 2014
RTHawk, HeartVista Workstation with RTHawk
K142997
Heartvista, Inc.
Radiology · 68d
Cleared Dec 05, 2014
Discovery MR750 3.0T
K142361
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
K141977
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Oct 23, 2014
SUPERNOVA C5 MRI SYSTEM
K131737
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
K142515
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
K142085
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 19, 2014
VANTAGE ELAN
K141472
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Aug 07, 2014
LCD MONITOR
K140956
Nordicneurolab
Radiology · 115d
Cleared Jul 24, 2014
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
K133670
Neocoil, LLC
Radiology · 237d
Cleared Jun 25, 2014
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
K133848
Heartvista, Inc.
Radiology · 189d
Cleared Jun 13, 2014
MR ELASTOGRAPHY
K140666
Philips Medical Systems Nederland B.V.
Radiology · 87d