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 01, 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
234d
Cleared
Oct 18, 1999
PHILIPS GYROSCAN INTERA (*)
Philips Medical Systems North America, Inc.
Radiology
81d
Cleared
Oct 08, 1999
VIRGO MRI SYSTEM
Millennium Technology Services
Radiology
262d
Cleared
Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
Northwest Medical Physics Equipment, Inc.
Radiology
343d
Cleared
Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
Magnetic Moments, LLC
Radiology
20d
Cleared
Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
Philips Medical Systems North America, Inc.
Radiology
218d
Cleared
Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
Ge Medical Systems, Inc.
Radiology
76d
Cleared
Sep 07, 1999
QUANTITATIVE FLOW
Philips Medical Systems (Cleveland), Inc.
Radiology
67d
Cleared
Aug 23, 1999
MRGP OPTICAL TRACKING UNIT
Philips Medical Systems (Cleveland), Inc.
Radiology
75d
Cleared
Aug 17, 1999
IPASS BOLUS TRACKING
Philips Medical Systems (Cleveland), Inc.
Radiology
28d
Cleared
Aug 13, 1999
DYNAWELL OR DYNAWELL
Ekeroth Quality AB
Radiology
51d
Cleared
Aug 03, 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
Siemens Corp.
Radiology
82d
Cleared
Jun 18, 1999
NORMA 10
Odin Technologies , Ltd.
Radiology
67d
Cleared
May 27, 1999
E-SCAN
Biosound Esaote, Inc.
Radiology
65d
Cleared
May 14, 1999
EXCELART
Toshiba America Mri, Inc.
Radiology
78d
Cleared
May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
Ge Medical Systems, Inc.
Radiology
78d
Cleared
Apr 15, 1999
OPART
Toshiba America Mri, Inc.
Radiology
78d
Cleared
Feb 25, 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
Toshiba America Mri, Inc.
Radiology
174d
Cleared
Feb 12, 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
Siemens Corp.
Radiology
79d
Cleared
Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
Hitachi Medical Systems America, Inc.
Radiology
70d
Cleared
Feb 02, 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
Siemens Corp.
Radiology
69d
Cleared
Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
Radiology
56d
Cleared
Jan 07, 1999
FIELD EFFECTS MRI SYSTEM
Intermagnetics General Corp.
Radiology
65d
Cleared
Nov 03, 1998
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
Medrad, Inc.
Radiology
71d