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