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
Mar 09, 1990
MRT 50A 150MM CIRCULAR SURFACE COIL
Toshiba America Mri, Inc.
Radiology
46d
Cleared
Mar 09, 1990
MRT 50A FLEXIBLE BODY COIL
Toshiba America Mri, Inc.
Radiology
46d
Cleared
Mar 09, 1990
MRT 50A BRAIN QD COIL
Toshiba America Mri, Inc.
Radiology
46d
Cleared
Mar 09, 1990
MRT 50A 100MM CIRCULAR SURFACE COIL
Toshiba America Mri, Inc.
Radiology
46d
Cleared
Mar 09, 1990
MRT 50A JOINT COIL
Toshiba America Mri, Inc.
Radiology
22d
Cleared
Mar 09, 1990
MRT 50A KNEE COIL
Toshiba America Mri, Inc.
Radiology
22d
Cleared
Mar 08, 1990
MRT 50A SPINE SURFACE COIL
Toshiba America Mri, Inc.
Radiology
45d
Cleared
Mar 08, 1990
MRT 50A CRANIO-CERVICAL COIL
Toshiba America Mri, Inc.
Radiology
45d
Cleared
Feb 02, 1990
MODEL 8100
Medical Advances, Inc.
Radiology
136d
Cleared
Feb 02, 1990
MODEL: GYREX VERSION V
Elscint, Inc.
Radiology
86d
Cleared
Jan 23, 1990
MODEL 6000
Medical Advances, Inc.
Radiology
50d
Cleared
Jan 12, 1990
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
Instrumentarium Imaging, Inc.
Radiology
72d
Cleared
Jan 12, 1990
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
58d
Cleared
Jan 04, 1990
MODEL 5070
Medical Advances, Inc.
Radiology
157d
Cleared
Dec 22, 1989
MODEL SPINE SURVEYOR-PLUS
Medical Advances, Inc.
Radiology
49d
Cleared
Dec 21, 1989
GYROVIEW HR HIGH RESOLUTION WORKSTATION
Philips Medical Systems North America, Inc.
Radiology
27d
Cleared
Dec 14, 1989
GYROSCAN T5 MOBILE
Philips Medical Systems, Inc.
Radiology
71d
Cleared
Nov 30, 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
Siemens Medical Solutions USA, Inc.
Radiology
50d
Cleared
Nov 22, 1989
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20
Summit World Trade Corp.
Radiology
169d
Cleared
Nov 17, 1989
GE MR MAX SYSTEM
GE Medical Systems
Radiology
50d
Cleared
Nov 15, 1989
1989 SOFTWARE REVISION TO THE BMT-1100
Bruker Medical Imaging, Inc.
Radiology
114d
Cleared
Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
Shimadzu Medical Systems
Radiology
172d
Cleared
Oct 30, 1989
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
81d
Cleared
Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
Diasonics, Inc.
Radiology
172d