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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
457–480 of 1101
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 Sep 29, 1997
KINEMATIC POSITIONERS
K972704
Ge Medical Systems, Inc.
Radiology · 73d
Cleared Aug 20, 1997
ASSET APOLLO
K971884
Philips Medical Systems (Cleveland), Inc.
Radiology · 90d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668
GE Medical Systems
Radiology · 79d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573
Toshiba America Mri, Inc.
Radiology · 157d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068
Toshiba America Medical Systems, In.C
Radiology · 209d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
K971380
Medrad, Inc.
Radiology · 80d
Cleared Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
K965044
Elscint, Inc.
Radiology · 185d
Cleared Jun 05, 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
K970852
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990
Philips Medical Systems, Inc.
Radiology · 237d