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
385–408 of 1110
Cleared Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
K102155
Ge Medical Systems, LLC
Radiology · 32d
Cleared Jul 28, 2010
MROPEN
K101295
Paramed S.R.L.
Radiology · 79d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738
Medtec, Inc.
Radiology · 161d
Cleared Apr 05, 2010
MR INSPIRE WITH EXTENDED KIT
K100164
Paramed S.R.L.
Radiology · 75d
Cleared Mar 24, 2010
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
K093984
Time Medical Limited
Radiology · 90d
Cleared Mar 16, 2010
POLESTAR, MODEL N-30
K092308
Medtronic Navigation Israel, Ltd.
Radiology · 229d
Cleared Mar 11, 2010
DIAGNOSOFT HARP MODEL 2.06
K100352
Diagnosoft, Inc.
Radiology · 27d
Cleared Mar 05, 2010
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
K093336
Medical Numerics, Inc.
Radiology · 130d
Cleared Jan 06, 2010
3D ASL
K092925
Ge Medical Systems, LLC
Radiology · 105d
Cleared Dec 23, 2009
O-SCAN MR SYSTEM
K092469
Esaote, S.P.A.
Radiology · 134d
Cleared Nov 25, 2009
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
K092230
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
K092899
Ningbo Xingaoyi Magnetism Co., Ltd.
Radiology · 50d
Cleared Oct 08, 2009
MODIFICATION TO FMRI HARDWARE SYSTEM
K092253
Nordicneurolab
Radiology · 72d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237
Neusoft Medical Systems Co., Ltd.
Radiology · 48d
Cleared Sep 02, 2009
IMRX
K091166
Imris, Inc.
Radiology · 133d
Cleared Jul 24, 2009
MR-TOUCH OPTION
K083421
Ge Medical Systems, LLC
Radiology · 247d
Cleared Jul 24, 2009
PICA WHOLE BODY MRI SYSTEM
K091580
Time Medical Limited
Radiology · 52d
Cleared Jul 20, 2009
PERFSCAPE
K091444
Olea Medical
Radiology · 66d
Cleared Jul 17, 2009
OPTIMA MR450W
K091536
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jun 18, 2009
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
K091669
Xioao Mdt Technology Co, Ltd.
Radiology · 9d
Cleared Apr 28, 2009
SYNGO BREVIS
K090038
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Apr 10, 2009
I OPEN 0.5T
K090873
Beijing Wandong Medical Equipment Co., Ltd.
Radiology · 10d
Cleared Mar 25, 2009
I_OPEN 0.4T
K090433
Beijing Wandong Medical Equipment Co., Ltd.
Radiology · 34d
Cleared Mar 23, 2009
CIRRUS OPEN
K090080
Mri-Tech Sp. Zo.O.
Radiology · 70d