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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
553–576 of 1104
Cleared Nov 02, 1998
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
K982932
Medrad, Inc.
Radiology · 74d
Cleared Oct 29, 1998
RESTGRID PACKAGE/GYROSCAN NT
K982834
Philips Medical Systems North America, Inc.
Radiology · 78d
Cleared Oct 22, 1998
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
K982761
Chamco, Inc.
Radiology · 77d
Cleared Oct 09, 1998
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
K983327
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 02, 1998
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K982157
Field Effects
Radiology · 75d
Cleared Aug 27, 1998
IMAGE POST-PROCESSING TECHNIQUES
K980831
Philips Medical Systems (Cleveland), Inc.
Radiology · 176d
Cleared Aug 03, 1998
ORTHOVU-1000
K981898
Magnevu
Radiology · 63d
Cleared Jul 14, 1998
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
K981475
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Jun 30, 1998
HIGH IMPEDANCE CARDIAC GATING CABLE
K981190
GE Medical Systems
Radiology · 89d
Cleared Jun 30, 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410
Philips Medical Systems (Cleveland), Inc.
Radiology · 71d
Cleared Jun 01, 1998
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
K981398
Interneuron Pharmaceuticals, Inc.
Radiology · 45d
Cleared May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645
Philips Medical Systems North America, Inc.
Radiology · 81d
Cleared May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658
Philips Medical Systems North America, Inc.
Radiology · 223d
Cleared May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
K980417
Medrad, Inc.
Radiology · 90d
Cleared Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
K980306
Elscint, Inc.
Radiology · 65d
Cleared Mar 30, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K980114
GE Medical Systems
Radiology · 76d
Cleared Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844
Philips Medical Systems (Cleveland), Inc.
Radiology · 76d
Cleared Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
K974614
Elscint, Inc.
Radiology · 83d
Cleared Feb 26, 1998
STRATIS II
K974498
Hitachi Medical Systems America, Inc.
Radiology · 90d
Cleared Feb 09, 1998
AIRIS II
K974212
Hitachi Medical Systems America, Inc.
Radiology · 91d
Cleared Feb 06, 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530
Philips Medical Systems (Cleveland), Inc.
Radiology · 66d
Cleared Feb 05, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990
GE Medical Systems
Radiology · 177d
Cleared Jan 02, 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826
Elscint Mr, Inc.
Radiology · 78d