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
505–528 of 1101
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
Cleared Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646
Philips Medical Systems (Cleveland), Inc.
Radiology · 100d
Cleared Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
K945945
Philips Medical Systems North America, Inc.
Radiology · 382d
Cleared Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604
GE Medical Systems
Radiology · 541d
Cleared Nov 24, 1995
GYREX PRIVILEGE
K954039
Elscint, Inc.
Radiology · 88d
Cleared Nov 14, 1995
CLINICAL PROTON SPECTROSCOPY OPTION
K951650
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared Nov 14, 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
K954355
General Electric Co.
Radiology · 57d
Cleared Oct 23, 1995
IRIS BILATERAL TMJ
K953248
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Oct 17, 1995
QD BILATERAL BREAST COIL
K953262
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
K945517
Siemens Medical Solutions USA, Inc.
Radiology · 332d
Cleared Sep 19, 1995
GYRES 2T PRESTIGE
K945791
Elscint, Inc.
Radiology · 298d
Cleared Sep 18, 1995
OUTLOOK
K945827
Philips Medical Systems (Cleveland), Inc.
Radiology · 293d
Cleared Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K953918
Hitachi Medical Systems America, Inc.
Radiology · 25d
Cleared Aug 23, 1995
MAGNETOM VISION (PROJECT 016)
K945779
Siemens Medical Solutions USA, Inc.
Radiology · 271d