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
577–600 of 1104
Cleared Sep 29, 1997
KINEMATIC POSITIONERS
K972704
Ge Medical Systems, Inc.
Radiology · 73d
Cleared Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
K970990
Elscint Mr, Inc.
Radiology · 160d
Cleared Aug 20, 1997
ASSET APOLLO
K971884
Philips Medical Systems (Cleveland), Inc.
Radiology · 90d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668
GE Medical Systems
Radiology · 79d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573
Toshiba America Mri, Inc.
Radiology · 157d
Cleared Jul 15, 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068
Toshiba America Medical Systems, In.C
Radiology · 209d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
K971380
Medrad, Inc.
Radiology · 80d
Cleared Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
K965044
Elscint, Inc.
Radiology · 185d
Cleared Jun 05, 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
K970852
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990
Philips Medical Systems, Inc.
Radiology · 237d
Cleared Mar 28, 1997
ARTOSCAN M
K963262
Biosound, Inc.
Radiology · 220d
Cleared Mar 12, 1997
TARGOGRID
K970037
Daum GmbH
Radiology · 65d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752
Philips Medical Systems (Cleveland), Inc.
Radiology · 89d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778
Health Images, Inc.
Radiology · 89d
Cleared Feb 11, 1997
MATRIX 3000 FLEXIBLE SPINE COIL
K964753
Us Asia Instruments, Inc.
Radiology · 76d
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 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
K964531
Us Asia Instruments, Inc.
Radiology · 73d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306
General Electric Co.
Radiology · 80d
Cleared Jan 10, 1997
PIXELL MRI SYSTEM
K962249
General Medical Equipment Corp.
Radiology · 213d
Cleared Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370
GE Medical Systems
Radiology · 70d