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
May 31, 1990
MODEL 4050-21
Medical Advances, Inc.
Radiology
36d
Cleared
May 23, 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
Siemens Medical Solutions USA, Inc.
Radiology
30d
Cleared
May 14, 1990
MODEL 4050-64
Medical Advances, Inc.
Radiology
35d
Cleared
May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
Resonex, Inc.
Radiology
31d
Cleared
May 07, 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
Instrumentarium Imaging, Inc.
Radiology
32d
Cleared
Apr 26, 1990
MODEL 2121-64
Medical Advances, Inc.
Radiology
42d
Cleared
Apr 26, 1990
MODEL 2121-21, TMJ SURFACE COIL
Medical Advances, Inc.
Radiology
37d
Cleared
Apr 26, 1990
MODEL 6000-21
Medical Advances, Inc.
Radiology
31d
Cleared
Apr 25, 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
Medical Advances, Inc.
Radiology
41d
Cleared
Apr 05, 1990
MODEL 8010
Medical Advances, Inc.
Radiology
29d
Cleared
Mar 23, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
Siemens Medical Solutions USA, Inc.
Radiology
24d
Cleared
Mar 19, 1990
MRT 50A SOFTWARE RELEASE 9.0
Toshiba America Mri, Inc.
Radiology
56d
Cleared
Mar 09, 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
64d
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