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
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
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 19, 1995
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
General Electric Co.
Radiology
440d
Cleared
Jun 13, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
GE Medical Systems
Radiology
245d
Cleared
Jun 05, 1995
THIN-FILM CARDIAC GATING CABLE
General Electric Co.
Radiology
174d
Cleared
May 24, 1995
AIRIS
Hitachi Medical Systems America, Inc.
Radiology
215d
Cleared
May 12, 1995
MRH-1500
Hitachi Medical Systems America, Inc.
Radiology
282d
Cleared
May 11, 1995
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
70d
Cleared
Apr 20, 1995
MRT-50 QD BODY COIL
Toshiba America Mri, Inc.
Radiology
140d
Cleared
Apr 12, 1995
ECHO PLANAR IMAGING I
Philips Medical Systems (Cleveland), Inc.
Radiology
134d
Cleared
Apr 06, 1995
FLEXART(TM) QD C-SPINE COIL
Toshiba America Mri, Inc.
Radiology
140d
Cleared
Apr 06, 1995
MRT-35A UPGRADE 8.0CD
Toshiba America Mri, Inc.
Radiology
129d
Cleared
Mar 23, 1995
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
Medical Advances, Inc.
Radiology
118d
Cleared
Mar 21, 1995
STRATIS
Hitachi Medical Systems America, Inc.
Radiology
138d
Cleared
Feb 09, 1995
ANGIO II
Philips Medical Systems (Cleveland), Inc.
Radiology
98d
Cleared
Feb 08, 1995
ACCESS(TM) COMPASS BED
Toshiba America Mri, Inc.
Radiology
48d
Cleared
Feb 02, 1995
SMT-50CX/H
Shimadzu Medical Systems
Radiology
241d
Cleared
Jan 26, 1995
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
Siemens Medical Solutions USA, Inc.
Radiology
297d
Cleared
Jan 26, 1995
MRT-150A, MRT-150A SOFTWARE VERSION 11.9
Toshiba America Mri, Inc.
Radiology
283d
Cleared
Jan 25, 1995
MODEL 528GE SERIES
Medical Advances, Inc.
Radiology
141d
Cleared
Jan 25, 1995
GENERAL PURPOSE FLEX COIL
Philips Medical Systems (Cleveland), Inc.
Radiology
138d