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..
1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
Cleared
May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
Philips Medical Systems North America, Inc.
Radiology
81d
Cleared
May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
Philips Medical Systems North America, Inc.
Radiology
223d
Cleared
May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
Medrad, Inc.
Radiology
90d
Cleared
Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
Elscint, Inc.
Radiology
65d
Cleared
Mar 30, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
76d
Cleared
Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
Philips Medical Systems (Cleveland), Inc.
Radiology
76d
Cleared
Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
Elscint, Inc.
Radiology
83d
Cleared
Feb 26, 1998
STRATIS II
Hitachi Medical Systems America, Inc.
Radiology
90d
Cleared
Feb 09, 1998
AIRIS II
Hitachi Medical Systems America, Inc.
Radiology
91d
Cleared
Feb 06, 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
Philips Medical Systems (Cleveland), Inc.
Radiology
66d
Cleared
Feb 05, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
177d
Cleared
Jan 02, 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
Siemens Medical Solutions USA, Inc.
Radiology
88d
Cleared
Sep 29, 1997
KINEMATIC POSITIONERS
Ge Medical Systems, Inc.
Radiology
73d
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