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
Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
Medrad, Inc.
Radiology
80d
Cleared
Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
Siemens Medical Solutions USA, Inc.
Radiology
88d
Cleared
Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
Elscint, Inc.
Radiology
185d
Cleared
Jun 05, 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
Siemens Medical Solutions USA, Inc.
Radiology
90d
Cleared
May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
Philips Medical Systems, Inc.
Radiology
237d
Cleared
Mar 28, 1997
ARTOSCAN M
Biosound, Inc.
Radiology
220d
Cleared
Mar 12, 1997
TARGOGRID
Daum GmbH
Radiology
65d
Cleared
Feb 24, 1997
KINEMATIC POSITIONING DEVICES
Philips Medical Systems (Cleveland), Inc.
Radiology
89d
Cleared
Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
Health Images, Inc.
Radiology
89d
Cleared
Feb 11, 1997
MATRIX 3000 FLEXIBLE SPINE COIL
Us Asia Instruments, Inc.
Radiology
76d
Cleared
Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
Philips Medical Systems (Cleveland), Inc.
Radiology
83d
Cleared
Feb 04, 1997
MRT-35A V9.0
Toshiba America Mri, Inc.
Radiology
78d
Cleared
Jan 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
Us Asia Instruments, Inc.
Radiology
73d
Cleared
Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
Radiology
80d
Cleared
Jan 10, 1997
PIXELL MRI SYSTEM
General Medical Equipment Corp.
Radiology
213d
Cleared
Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
70d
Cleared
Dec 23, 1996
FLEXART V3.1 SOFTWARE
Toshiba America Mri, Inc.
Radiology
203d
Cleared
Dec 18, 1996
IMIG-MRI
Imig-Mri Systems, LLC
Radiology
77d
Cleared
Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
183d
Cleared
Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
89d
Cleared
Nov 12, 1996
ORTHO 8000
Inner Vision Mri , Ltd.
Radiology
90d
Cleared
Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
85d
Cleared
Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
Siemens Medical Solutions USA, Inc.
Radiology
97d
Cleared
Oct 25, 1996
OPART MRT-600
Toshiba America Mri, Inc.
Radiology
88d