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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
289–312 of 1110
Cleared Dec 24, 2015
MAGNETOM Amira
K152283
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Dec 22, 2015
Magnetic Reasonance Imaging System
K151074
Jiangsu Magspin Instrument Co.,Ltd
Radiology · 244d
Cleared Oct 27, 2015
SIGNA Pioneer
K153003
Ge Healthcare
Radiology · 14d
Cleared Oct 23, 2015
Vantage Titan 3T
K152371
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Oct 15, 2015
MrOpen
K151466
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
K151579
Siemens Medical Solutions USA, Inc.
Radiology · 110d
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