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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
649–672 of 1101
Cleared Oct 21, 1992
A BREAST COIL FOR THE GYREX 2T-DIX
K923897
Elscint, Inc.
Radiology · 78d
Cleared Oct 09, 1992
VISTA HPQ SYSTEM
K923615
Philips Medical Systems (Cleveland), Inc.
Radiology · 80d
Cleared Sep 30, 1992
GENERAL PURPOSE FLEX COIL
K923264
General Electric Co.
Radiology · 90d
Cleared Sep 14, 1992
QD WHOLE BODY COIL, MRT-150A
K922798
Toshiba America Mri, Inc.
Radiology · 96d
Cleared Aug 25, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K923010
Hitachi Medical Systems America, Inc.
Radiology · 64d
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 Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441
Hitachi Medical Systems America, Inc.
Radiology · 178d
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 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 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 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
Cleared Mar 06, 1992
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
K920199
Philips Medical Systems (Cleveland), Inc.
Radiology · 51d
Cleared Mar 05, 1992
MODEL 310GE-64: WHOLE VOLUME NECK COIL
K914209
Medical Advances, Inc.
Radiology · 168d
Cleared Mar 05, 1992
MOBILE MRP-7000
K920159
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
K915579
Elscint, Inc.
Radiology · 67d