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
Nov 21, 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
Siemens Medical Solutions USA, Inc.
Radiology
69d
Cleared
Nov 21, 1988
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
62d
Cleared
Nov 14, 1988
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
Toshiba Medical Systems
Radiology
69d
Cleared
Nov 10, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
Instrumentarium Corp.
Radiology
77d
Cleared
Oct 19, 1988
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
64d
Cleared
Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
Philips Medical Systems (Cleveland), Inc.
Radiology
62d
Cleared
Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
Instrumentarium Corp.
Radiology
51d
Cleared
Oct 13, 1988
VFQ HEAD COIL
Resonex, Inc.
Radiology
42d
Cleared
Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
Diasonics, Inc.
Radiology
52d
Cleared
Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
Philips Medical Systems (Cleveland), Inc.
Radiology
50d
Cleared
Sep 22, 1988
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
44d
Cleared
Sep 16, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
Instrumentarium Corp.
Radiology
18d
Cleared
Sep 14, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
Instrumentarium Corp.
Radiology
20d
Cleared
Sep 02, 1988
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS
Philips Medical Systems (Cleveland), Inc.
Radiology
15d