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
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 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
Cleared
Mar 16, 1992
16 BIT A/D
Resonex, Inc.
Radiology
84d
Cleared
Mar 06, 1992
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
Philips Medical Systems (Cleveland), Inc.
Radiology
51d
Cleared
Mar 05, 1992
MODEL 310GE-64: WHOLE VOLUME NECK COIL
Medical Advances, Inc.
Radiology
168d
Cleared
Mar 05, 1992
MOBILE MRP-7000
Hitachi Medical Systems America, Inc.
Radiology
51d
Cleared
Feb 27, 1992
INSTRUMENTARIUM MEGA4
Instrumentarium Imaging, Inc.
Radiology
78d
Cleared
Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
Elscint, Inc.
Radiology
67d
Cleared
Feb 14, 1992
GYREX 2T-DLX
Elscint, Inc.
Radiology
63d
Cleared
Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
Elscint, Inc.
Radiology
49d
Cleared
Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
General Electric Co.
Radiology
157d
Cleared
Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
Siemens Medical Solutions USA, Inc.
Radiology
55d
Cleared
Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
General Electric Co.
Radiology
127d
Cleared
Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
Siemens Medical Solutions USA, Inc.
Radiology
44d