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
889–912 of 1104
Cleared May 31, 1990
MODEL 4050-21
K901864
Medical Advances, Inc.
Radiology · 36d
Cleared May 23, 1990
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 14, 1990
MODEL 4050-64
K901639
Medical Advances, Inc.
Radiology · 35d
Cleared May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602
Resonex, Inc.
Radiology · 31d
Cleared May 07, 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
K901620
Instrumentarium Imaging, Inc.
Radiology · 32d
Cleared Apr 26, 1990
MODEL 2121-64
K901242
Medical Advances, Inc.
Radiology · 42d
Cleared Apr 26, 1990
MODEL 2121-21, TMJ SURFACE COIL
K901305
Medical Advances, Inc.
Radiology · 37d
Cleared Apr 26, 1990
MODEL 6000-21
K901384
Medical Advances, Inc.
Radiology · 31d
Cleared Apr 25, 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
K901241
Medical Advances, Inc.
Radiology · 41d
Cleared Apr 05, 1990
MODEL 8010
K901092
Medical Advances, Inc.
Radiology · 29d
Cleared Mar 23, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K900889
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Mar 19, 1990
MRT 50A SOFTWARE RELEASE 9.0
K900283
Toshiba America Mri, Inc.
Radiology · 56d
Cleared Mar 09, 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d
Cleared Mar 09, 1990
MRT 50A 150MM CIRCULAR SURFACE COIL
K900284
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A FLEXIBLE BODY COIL
K900285
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A BRAIN QD COIL
K900288
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A 100MM CIRCULAR SURFACE COIL
K900289
Toshiba America Mri, Inc.
Radiology · 46d
Cleared Mar 09, 1990
MRT 50A JOINT COIL
K900727
Toshiba America Mri, Inc.
Radiology · 22d
Cleared Mar 09, 1990
MRT 50A KNEE COIL
K900728
Toshiba America Mri, Inc.
Radiology · 22d
Cleared Mar 08, 1990
MRT 50A SPINE SURFACE COIL
K900286
Toshiba America Mri, Inc.
Radiology · 45d
Cleared Mar 08, 1990
MRT 50A CRANIO-CERVICAL COIL
K900287
Toshiba America Mri, Inc.
Radiology · 45d
Cleared Feb 02, 1990
MODEL 8100
K895629
Medical Advances, Inc.
Radiology · 136d
Cleared Feb 02, 1990
MODEL: GYREX VERSION V
K896419
Elscint, Inc.
Radiology · 86d
Cleared Jan 23, 1990
MODEL 6000
K896789
Medical Advances, Inc.
Radiology · 50d