LNH · Class II · 21 CFR 892.1000

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
721–744 of 1110
Cleared Jun 19, 1995
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
K941666
General Electric Co.
Radiology · 440d
Cleared Jun 19, 1995
ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING
K944070
Advanced Nmr Systems, Inc.
Radiology · 304d
Cleared Jun 13, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944979
GE Medical Systems
Radiology · 245d
Cleared Jun 05, 1995
THIN-FILM CARDIAC GATING CABLE
K946085
General Electric Co.
Radiology · 174d
Cleared May 24, 1995
AIRIS
K945155
Hitachi Medical Systems America, Inc.
Radiology · 215d
Cleared May 12, 1995
MRH-1500
K943798
Hitachi Medical Systems America, Inc.
Radiology · 282d
Cleared May 11, 1995
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K950973
GE Medical Systems
Radiology · 70d
Cleared Apr 20, 1995
MRT-50 QD BODY COIL
K945875
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 12, 1995
ECHO PLANAR IMAGING I
K945828
Philips Medical Systems (Cleveland), Inc.
Radiology · 134d
Cleared Apr 10, 1995
ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
K940772
Fonar Corp.
Radiology · 412d
Cleared Apr 06, 1995
FLEXART(TM) QD C-SPINE COIL
K945665
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 06, 1995
MRT-35A UPGRADE 8.0CD
K945798
Toshiba America Mri, Inc.
Radiology · 129d
Cleared Mar 23, 1995
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
K945778
Medical Advances, Inc.
Radiology · 118d
Cleared Mar 21, 1995
STRATIS
K945386
Hitachi Medical Systems America, Inc.
Radiology · 138d
Cleared Feb 09, 1995
ANGIO II
K945397
Philips Medical Systems (Cleveland), Inc.
Radiology · 98d
Cleared Feb 08, 1995
ACCESS(TM) COMPASS BED
K946244
Toshiba America Mri, Inc.
Radiology · 48d
Cleared Feb 02, 1995
SMT-50CX/H
K942669
Shimadzu Medical Systems
Radiology · 241d
Cleared Jan 26, 1995
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
K941622
Siemens Medical Solutions USA, Inc.
Radiology · 297d
Cleared Jan 26, 1995
MRT-150A, MRT-150A SOFTWARE VERSION 11.9
K941864
Toshiba America Mri, Inc.
Radiology · 283d
Cleared Jan 25, 1995
MODEL 528GE SERIES
K944331
Medical Advances, Inc.
Radiology · 141d
Cleared Jan 25, 1995
GENERAL PURPOSE FLEX COIL
K944469
Philips Medical Systems (Cleveland), Inc.
Radiology · 138d
Cleared Jan 25, 1995
FLEXART QD BODY COIL
K944662
Toshiba America Mri, Inc.
Radiology · 126d
Cleared Jan 25, 1995
MODEL 405GE-64: PHASED ARRAY TMJ COIL
K944773
Medical Advances, Inc.
Radiology · 120d
Cleared Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
K943800
Hitachi Medical Systems America, Inc.
Radiology · 149d