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
Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
Toshiba America Mri, Inc.
Radiology
71d
Cleared
Oct 17, 2000
HITACHI ALTAIRE
Hitachi Medical Systems America, Inc.
Radiology
70d
Cleared
Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
84d
Cleared
Sep 06, 2000
GYROSCAN INTERA (R7.5)
Philips Medical Systems North America, Inc.
Radiology
84d
Cleared
Sep 06, 2000
EXPLORER GRADIENT
Philips Medical Systems North America, Inc.
Radiology
69d
Cleared
Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
Medis Medical Imaging Systems BV
Radiology
254d
Cleared
Aug 18, 2000
POWERDRIVE 350 OPTION
Philips Medical Systems (Cleveland), Inc.
Radiology
10d
Cleared
Aug 08, 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
15d
Cleared
Jul 06, 2000
HITACHI AIRIS II
Hitachi Medical Systems America, Inc.
Radiology
70d
Cleared
Jul 06, 2000
MODIFICATION TO E-SCAN
Biosound Esaote, Inc.
Radiology
15d
Cleared
May 26, 2000
SPIRAL IMAGING OPTION
GE Medical Systems
Radiology
74d
Cleared
Apr 27, 2000
STEROTACTIC LOCALIZATION DEVICE (SLD)
Philips Medical Systems North America, Inc.
Radiology
44d
Cleared
Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
GE Medical Systems
Radiology
55d
Cleared
Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
Resonance Technology, Inc.
Radiology
90d
Cleared
Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
Fonar Corp.
Radiology
87d
Cleared
Mar 02, 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
Medis Medical Imaging Systems BV
Radiology
73d
Cleared
Feb 06, 2000
EXCELART WITH PIANISSIMO
Toshiba America Mri, Inc.
Radiology
89d
Cleared
Feb 04, 2000
MR ENHANCER
I.Z.I. Corp.
Radiology
60d
Cleared
Jan 20, 2000
MRI EQUIPMENT COVER
Image-Guided Neurologics, Inc.
Radiology
80d
Cleared
Jan 18, 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
Toshiba America Mri, Inc.
Radiology
89d
Cleared
Jan 14, 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
Siemens Medical Corp.
Radiology
23d
Cleared
Dec 23, 1999
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
Philips Medical Systems North America, Inc.
Radiology
308d
Cleared
Nov 09, 1999
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
Ge Medical Systems, Inc.
Radiology
85d