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
889–912 of 1110
Cleared Aug 20, 1992
VISTA HPQ SYSTEM
K920714
Philips Medical Systems (Cleveland), Inc.
Radiology · 184d
Cleared Aug 14, 1992
MRT-50
K921413
Toshiba America Mri, Inc.
Radiology · 143d
Cleared Aug 05, 1992
INSTASCAN
K920204
Advanced Nmr Systems, Inc.
Radiology · 202d
Cleared Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Jul 29, 1992
QQUADRATURE LUMBAR CONTOUR COIL
K922006
Magnetic Research, Inc.
Radiology · 90d
Cleared Jul 28, 1992
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
K922000
Mri Devices Corp.
Radiology · 90d
Cleared Jul 17, 1992
VISTA HPQ SYSTEM
K921881
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Jul 16, 1992
MRT-50A QD SPINE COIL
K921720
Toshiba America Mri, Inc.
Radiology · 98d
Cleared Jul 10, 1992
MRT-150 QD KNEE COIL
K920096
Toshiba America Mri, Inc.
Radiology · 184d
Cleared Jul 10, 1992
MRI OE 1.5 SI
K920543
Otsuka Electronics
Radiology · 156d
Cleared Jun 25, 1992
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K920789
Fonar Corp.
Radiology · 125d
Cleared Jun 22, 1992
COILS FOR RX4000 & RX5000 MRI SYSTEMS
K920254
Resonex, Inc.
Radiology · 153d
Cleared Jun 15, 1992
VISTA HP/HPQ SYSTEM
K921609
Philips Medical Systems (Cleveland), Inc.
Radiology · 73d
Cleared Jun 09, 1992
ACCESS QD HEAD COIL
K920098
Toshiba America Mri, Inc.
Radiology · 153d
Cleared May 28, 1992
BO POWER SUPPLY
K921046
Resonex, Inc.
Radiology · 85d
Cleared May 22, 1992
PRESATURATION
K920835
Resonex, Inc.
Radiology · 88d
Cleared May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)
K915567
Fonar Corp.
Radiology · 155d
Cleared May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K920094
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared May 15, 1992
MAGNETOM 63SP
K921098
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Apr 28, 1992
MRT-50 MULTIVIEW COIL
K920095
Toshiba America Mri, Inc.
Radiology · 111d
Cleared Apr 14, 1992
INSTRUMENTARIUM MEGA4 HT
K920215
Instrumentarium Imaging, Inc.
Radiology · 89d
Cleared Apr 06, 1992
MRT-50 FLEXIBLE BODY COIL
K920126
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Mar 31, 1992
MRT-50 QD HEAD COIL
K920097
Toshiba America Mri, Inc.
Radiology · 83d
Cleared Mar 31, 1992
MRT-50 SPINE COIL
K920125
Toshiba America Mri, Inc.
Radiology · 81d