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
481–504 of 1101
Cleared Mar 28, 1997
ARTOSCAN M
K963262
Biosound, Inc.
Radiology · 220d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752
Philips Medical Systems (Cleveland), Inc.
Radiology · 89d
Cleared Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626
Philips Medical Systems (Cleveland), Inc.
Radiology · 83d
Cleared Feb 04, 1997
MRT-35A V9.0
K964608
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306
General Electric Co.
Radiology · 80d
Cleared Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370
GE Medical Systems
Radiology · 70d
Cleared Dec 23, 1996
FLEXART V3.1 SOFTWARE
K962138
Toshiba America Mri, Inc.
Radiology · 203d
Cleared Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K962061
GE Medical Systems
Radiology · 183d
Cleared Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963429
GE Medical Systems
Radiology · 89d
Cleared Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963179
GE Medical Systems
Radiology · 85d
Cleared Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
K962892
Siemens Medical Solutions USA, Inc.
Radiology · 97d
Cleared Oct 25, 1996
OPART MRT-600
K962933
Toshiba America Mri, Inc.
Radiology · 88d
Cleared Oct 18, 1996
FLEXART TMJ COIL
K961624
Toshiba America Mri, Inc.
Radiology · 175d
Cleared Oct 18, 1996
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
K963345
GE Medical Systems
Radiology · 53d
Cleared Sep 25, 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 05, 1996
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
K961969
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Sep 04, 1996
GYREX V-EP
K962618
Elscint, Inc.
Radiology · 63d
Cleared Aug 27, 1996
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
K962117
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Aug 14, 1996
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
K962048
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Aug 02, 1996
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
K961842
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Jul 25, 1996
AIRIS
K961876
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Jul 05, 1996
FLEXIBLE PHASED ARRAY SPINE COIL
K960497
Philips Medical Systems (Cleveland), Inc.
Radiology · 154d
Cleared Jul 03, 1996
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
K961366
Mri Devices Corp.
Radiology · 85d
Cleared Jun 28, 1996
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
K961238
Toshiba America Mri, Inc.
Radiology · 88d