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
601–624 of 1110
Cleared Aug 23, 1999
MRGP OPTICAL TRACKING UNIT
K991943
Philips Medical Systems (Cleveland), Inc.
Radiology · 75d
Cleared Aug 17, 1999
IPASS BOLUS TRACKING
K992412
Philips Medical Systems (Cleveland), Inc.
Radiology · 28d
Cleared Aug 13, 1999
DYNAWELL OR DYNAWELL
K992120
Ekeroth Quality AB
Radiology · 51d
Cleared Aug 03, 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K991652
Siemens Corp.
Radiology · 82d
Cleared Jun 18, 1999
NORMA 10
K991243
Odin Technologies , Ltd.
Radiology · 67d
Cleared May 27, 1999
E-SCAN
K990968
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 14, 1999
EXCELART
K990620
Toshiba America Mri, Inc.
Radiology · 78d
Cleared May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550
Ge Medical Systems, Inc.
Radiology · 78d
Cleared Apr 15, 1999
OPART
K990260
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Feb 25, 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
K983110
Toshiba America Mri, Inc.
Radiology · 174d
Cleared Feb 12, 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221
Siemens Corp.
Radiology · 79d
Cleared Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
K984280
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Feb 02, 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
K984224
Siemens Corp.
Radiology · 69d
Cleared Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
K984274
Hitachi Medical Systems America, Inc.
Radiology · 56d
Cleared Jan 07, 1999
FIELD EFFECTS MRI SYSTEM
K983902
Intermagnetics General Corp.
Radiology · 65d
Cleared Nov 03, 1998
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
K982959
Medrad, Inc.
Radiology · 71d
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