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
Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
Ge Medical Systems, LLC
Radiology
32d
Cleared
Jul 28, 2010
MROPEN
Paramed S.R.L.
Radiology
79d
Cleared
May 14, 2010
MRI PATIENT POSITIONING DEVICES
Medtec, Inc.
Radiology
161d
Cleared
Apr 05, 2010
MR INSPIRE WITH EXTENDED KIT
Paramed S.R.L.
Radiology
75d
Cleared
Mar 24, 2010
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
Time Medical Limited
Radiology
90d
Cleared
Mar 16, 2010
POLESTAR, MODEL N-30
Medtronic Navigation Israel, Ltd.
Radiology
229d
Cleared
Mar 11, 2010
DIAGNOSOFT HARP MODEL 2.06
Diagnosoft, Inc.
Radiology
27d
Cleared
Mar 05, 2010
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
Medical Numerics, Inc.
Radiology
130d
Cleared
Jan 06, 2010
3D ASL
Ge Medical Systems, LLC
Radiology
105d
Cleared
Dec 23, 2009
O-SCAN MR SYSTEM
Esaote, S.P.A.
Radiology
134d
Cleared
Nov 25, 2009
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
Time Medical Limited
Radiology
125d
Cleared
Nov 10, 2009
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
Ningbo Xingaoyi Magnetism Co., Ltd.
Radiology
50d
Cleared
Oct 08, 2009
MODIFICATION TO FMRI HARDWARE SYSTEM
Nordicneurolab
Radiology
72d
Cleared
Sep 09, 2009
NSM-S15 SYSTEM
Neusoft Medical Systems Co., Ltd.
Radiology
48d
Cleared
Sep 02, 2009
IMRX
Imris, Inc.
Radiology
133d
Cleared
Jul 24, 2009
MR-TOUCH OPTION
Ge Medical Systems, LLC
Radiology
247d
Cleared
Jul 24, 2009
PICA WHOLE BODY MRI SYSTEM
Time Medical Limited
Radiology
52d
Cleared
Jul 20, 2009
PERFSCAPE
Olea Medical
Radiology
66d
Cleared
Jul 17, 2009
OPTIMA MR450W
Ge Medical Systems, LLC
Radiology
52d
Cleared
Jun 18, 2009
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
Xioao Mdt Technology Co, Ltd.
Radiology
9d
Cleared
Apr 28, 2009
SYNGO BREVIS
Siemens Medical Solutions USA, Inc.
Radiology
112d
Cleared
Apr 10, 2009
I OPEN 0.5T
Beijing Wandong Medical Equipment Co., Ltd.
Radiology
10d
Cleared
Mar 25, 2009
I_OPEN 0.4T
Beijing Wandong Medical Equipment Co., Ltd.
Radiology
34d
Cleared
Mar 23, 2009
CIRRUS OPEN
Mri-Tech Sp. Zo.O.
Radiology
70d