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..

1104
Total
1104
Cleared
110d
Avg days
1988
Since
1104 devices
961–984 of 1104
Cleared Nov 21, 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Nov 21, 1988
VISTA MR 2055 HP SYSTEM
K883994
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d
Cleared Nov 14, 1988
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
K883756
Toshiba Medical Systems
Radiology · 69d
Cleared Nov 10, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883621
Instrumentarium Corp.
Radiology · 77d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649
Instrumentarium Corp.
Radiology · 51d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737
Resonex, Inc.
Radiology · 42d
Cleared Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
K883516
Diasonics, Inc.
Radiology · 52d
Cleared Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
K883520
Philips Medical Systems (Cleveland), Inc.
Radiology · 50d
Cleared Sep 22, 1988
VISTA MR 2055 HP SYSTEM
K883378
Philips Medical Systems (Cleveland), Inc.
Radiology · 44d
Cleared Sep 16, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
K883650
Instrumentarium Corp.
Radiology · 18d
Cleared Sep 14, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883622
Instrumentarium Corp.
Radiology · 20d
Cleared Sep 02, 1988
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS
K883521
Philips Medical Systems (Cleveland), Inc.
Radiology · 15d