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
673–696 of 1110
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 20, 1996
ESTEEM 1.5T MRI SYSTEM
K962677
Elscint Mr, Inc.
Radiology · 73d
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
Cleared Jun 21, 1996
ECG MONITOR MODEL DS-3130/3140
K961174
Hitachi Medical Systems America, Inc.
Radiology · 88d
Cleared Jun 19, 1996
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
K961121
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 14, 1996
VISART
K961092
Toshiba America Medical Systems, In.C
Radiology · 87d
Cleared Jun 10, 1996
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
K955389
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared May 29, 1996
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
K960901
Medrad, Inc.
Radiology · 85d
Cleared May 29, 1996
MOVABLE ADD-ON COUCH FOR OUTLOOK
K960973
Philips Medical Systems (Cleveland), Inc.
Radiology · 79d
Cleared Apr 19, 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
K960294
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954353
General Electric Co.
Radiology · 207d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354
General Electric Co.
Radiology · 207d
Cleared Mar 29, 1996
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
K955811
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Mar 05, 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
K960181
Hitachi Medical Systems America, Inc.
Radiology · 49d