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 20, 1992
VISTA HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
184d
Cleared
Aug 14, 1992
MRT-50
Toshiba America Mri, Inc.
Radiology
143d
Cleared
Aug 05, 1992
INSTASCAN
Advanced Nmr Systems, Inc.
Radiology
202d
Cleared
Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
Hitachi Medical Systems America, Inc.
Radiology
178d
Cleared
Jul 29, 1992
QQUADRATURE LUMBAR CONTOUR COIL
Magnetic Research, Inc.
Radiology
90d
Cleared
Jul 28, 1992
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
Mri Devices Corp.
Radiology
90d
Cleared
Jul 17, 1992
VISTA HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
88d
Cleared
Jul 16, 1992
MRT-50A QD SPINE COIL
Toshiba America Mri, Inc.
Radiology
98d
Cleared
Jul 10, 1992
MRT-150 QD KNEE COIL
Toshiba America Mri, Inc.
Radiology
184d
Cleared
Jul 10, 1992
MRI OE 1.5 SI
Otsuka Electronics
Radiology
156d
Cleared
Jun 25, 1992
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
Fonar Corp.
Radiology
125d
Cleared
Jun 22, 1992
COILS FOR RX4000 & RX5000 MRI SYSTEMS
Resonex, Inc.
Radiology
153d
Cleared
Jun 15, 1992
VISTA HP/HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
73d
Cleared
Jun 09, 1992
ACCESS QD HEAD COIL
Toshiba America Mri, Inc.
Radiology
153d
Cleared
May 28, 1992
BO POWER SUPPLY
Resonex, Inc.
Radiology
85d
Cleared
May 22, 1992
PRESATURATION
Resonex, Inc.
Radiology
88d
Cleared
May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)
Fonar Corp.
Radiology
155d
Cleared
May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
Siemens Medical Solutions USA, Inc.
Radiology
128d
Cleared
May 15, 1992
MAGNETOM 63SP
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Apr 28, 1992
MRT-50 MULTIVIEW COIL
Toshiba America Mri, Inc.
Radiology
111d
Cleared
Apr 14, 1992
INSTRUMENTARIUM MEGA4 HT
Instrumentarium Imaging, Inc.
Radiology
89d
Cleared
Apr 06, 1992
MRT-50 FLEXIBLE BODY COIL
Toshiba America Mri, Inc.
Radiology
87d
Cleared
Mar 31, 1992
MRT-50 QD HEAD COIL
Toshiba America Mri, Inc.
Radiology
83d
Cleared
Mar 31, 1992
MRT-50 SPINE COIL
Toshiba America Mri, Inc.
Radiology
81d