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
Sep 29, 1997
KINEMATIC POSITIONERS
Ge Medical Systems, Inc.
Radiology
73d
Cleared
Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
Elscint Mr, Inc.
Radiology
160d
Cleared
Aug 20, 1997
ASSET APOLLO
Philips Medical Systems (Cleveland), Inc.
Radiology
90d
Cleared
Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
Siemens Medical Solutions USA, Inc.
Radiology
90d
Cleared
Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
GE Medical Systems
Radiology
79d
Cleared
Jul 21, 1997
FLEXART V3.5 SOFTWARE
Toshiba America Mri, Inc.
Radiology
157d
Cleared
Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
Toshiba America Medical Systems, In.C
Radiology
209d
Cleared
Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
Radiology
87d
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