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
Feb 26, 1996
AURORA IMAGING SYSTEM
Advanced Mammography Systems, Inc.
Radiology
367d
Cleared
Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
Philips Medical Systems (Cleveland), Inc.
Radiology
100d
Cleared
Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
Philips Medical Systems North America, Inc.
Radiology
382d
Cleared
Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
GE Medical Systems
Radiology
541d
Cleared
Nov 24, 1995
GYREX PRIVILEGE
Elscint, Inc.
Radiology
88d
Cleared
Nov 14, 1995
CLINICAL PROTON SPECTROSCOPY OPTION
Siemens Medical Solutions USA, Inc.
Radiology
218d
Cleared
Nov 14, 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
General Electric Co.
Radiology
57d
Cleared
Nov 09, 1995
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
Fonar Corp.
Radiology
212d
Cleared
Oct 23, 1995
IRIS BILATERAL TMJ
Hitachi Medical Systems America, Inc.
Radiology
104d
Cleared
Oct 17, 1995
QD BILATERAL BREAST COIL
Hitachi Medical Systems America, Inc.
Radiology
96d
Cleared
Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
Radiology
332d
Cleared
Oct 06, 1995
PROFILE 7000 C-SPINE COIL
Us Asia Instruments, Inc.
Radiology
445d
Cleared
Sep 19, 1995
GYRES 2T PRESTIGE
Elscint, Inc.
Radiology
298d
Cleared
Sep 18, 1995
OUTLOOK
Philips Medical Systems (Cleveland), Inc.
Radiology
293d
Cleared
Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Hitachi Medical Systems America, Inc.
Radiology
25d
Cleared
Aug 30, 1995
HEALTH IMAGE INC. HI STAR
Health Images, Inc.
Radiology
339d
Cleared
Aug 23, 1995
MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
Radiology
271d
Cleared
Aug 09, 1995
MEDRAD QWIK-FIX MRI DISPOSABLE KIT
Medrad, Inc.
Radiology
400d
Cleared
Aug 09, 1995
SIGNA PROFILE
GE Medical Systems
Radiology
260d
Cleared
Jul 24, 1995
HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
Philips Medical Systems (Cleveland), Inc.
Radiology
53d
Cleared
Jul 20, 1995
HEALTH IMAGES, INC. HI-STANDARD
Health Images, Inc.
Radiology
323d
Cleared
Jun 26, 1995
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
Medrad, Inc.
Radiology
45d
Cleared
Jun 26, 1995
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
Medrad, Inc.
Radiology
45d
Cleared
Jun 22, 1995
MODEL #801GE1500 PEDIATRIC ARRAY COIL
Medic, Inc.
Radiology
73d