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
769–792 of 1104
Cleared Dec 18, 1992
MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG
K924426
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Nov 27, 1992
SIGNA BREAST COIL AND ARRAY ACCESSORY
K923025
GE Medical Systems
Radiology · 157d
Cleared Nov 27, 1992
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
K924349
General Electric Co.
Radiology · 92d
Cleared Nov 23, 1992
KINEMATIC MRI MOVIEMAKER
K924154
Resonex, Inc.
Radiology · 97d
Cleared Nov 10, 1992
MRT-35(TM)
K921940
Toshiba America Mri, Inc.
Radiology · 200d
Cleared Nov 09, 1992
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
K921941
General Electric Co.
Radiology · 199d
Cleared Nov 06, 1992
PHILIPS GYROSCAN T5 SERIES II
K920578
Philips Medical Systems North America, Inc.
Radiology · 270d
Cleared Nov 06, 1992
GYROSCAN S15/ACS-II
K920791
Philips Medical Systems, Inc.
Radiology · 259d
Cleared Oct 30, 1992
3D IMAGING
K923823
Resonex, Inc.
Radiology · 92d
Cleared Oct 21, 1992
A BREAST COIL FOR THE GYREX 2T-DIX
K923897
Elscint, Inc.
Radiology · 78d
Cleared Oct 09, 1992
VISTA HPQ SYSTEM
K923615
Philips Medical Systems (Cleveland), Inc.
Radiology · 80d
Cleared Oct 06, 1992
INSTRUMENTARIUM MEGA4 HT
K923352
Instrumentarium Imaging, Inc.
Radiology · 90d
Cleared Sep 30, 1992
GENERAL PURPOSE FLEX COIL
K923264
General Electric Co.
Radiology · 90d
Cleared Sep 22, 1992
INSTRUMENTARIUM MEGA4 HT
K923022
Instrumentarium Imaging, Inc.
Radiology · 91d
Cleared Sep 14, 1992
QD WHOLE BODY COIL, MRT-150A
K922798
Toshiba America Mri, Inc.
Radiology · 96d
Cleared Sep 04, 1992
MAGNETIZATION TRANSFER CONTRAST
K922677
Resonex, Inc.
Radiology · 92d
Cleared Aug 25, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K923010
Hitachi Medical Systems America, Inc.
Radiology · 64d
Cleared Aug 20, 1992
VISTA HPQ SYSTEM
K920714
Philips Medical Systems (Cleveland), Inc.
Radiology · 184d
Cleared Aug 14, 1992
MRT-50
K921413
Toshiba America Mri, Inc.
Radiology · 143d
Cleared Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Jul 28, 1992
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
K922000
Mri Devices Corp.
Radiology · 90d
Cleared Jul 17, 1992
VISTA HPQ SYSTEM
K921881
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Jul 16, 1992
MRT-50A QD SPINE COIL
K921720
Toshiba America Mri, Inc.
Radiology · 98d
Cleared Jul 10, 1992
MRT-150 QD KNEE COIL
K920096
Toshiba America Mri, Inc.
Radiology · 184d