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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
793–816 of 1104
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 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
Cleared Mar 16, 1992
16 BIT A/D
K915754
Resonex, Inc.
Radiology · 84d
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 27, 1992
INSTRUMENTARIUM MEGA4
K915552
Instrumentarium Imaging, Inc.
Radiology · 78d
Cleared Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
K915579
Elscint, Inc.
Radiology · 67d
Cleared Feb 14, 1992
GYREX 2T-DLX
K915601
Elscint, Inc.
Radiology · 63d
Cleared Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
K915598
Elscint, Inc.
Radiology · 49d
Cleared Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K913673
General Electric Co.
Radiology · 157d
Cleared Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
K915395
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
K913770
General Electric Co.
Radiology · 127d
Cleared Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112
Siemens Medical Solutions USA, Inc.
Radiology · 44d