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
Cleared
May 21, 1993
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
Radiology
252d
Cleared
May 19, 1993
MRINNERVU ENDORECTAL PROSTATE COIL
Medrad, Inc.
Radiology
226d
Cleared
Apr 27, 1993
PHILIPS GYROVIEW HR - RELEASE 2
Philips Medical Systems North America, Inc.
Radiology
265d
Cleared
Apr 27, 1993
MRT-50A SUPER
Toshiba America Mri, Inc.
Radiology
215d
Cleared
Apr 27, 1993
MRT-150A, QD SPINE COIL
Toshiba America Mri, Inc.
Radiology
140d
Cleared
Mar 18, 1993
FAST SPIN ECHO MEASURING FUNCTION
Hitachi Medical Systems America, Inc.
Radiology
87d
Cleared
Mar 16, 1993
SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM
Shimadzu Medical Systems
Radiology
221d
Cleared
Feb 12, 1993
2D TOF ANGIOGRAHY MEASURING FUNCTION
Hitachi Medical Systems America, Inc.
Radiology
135d
Cleared
Feb 02, 1993
VISTA HP/HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
76d
Cleared
Jan 15, 1993
SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Jan 15, 1993
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
Shimadzu Medical Systems
Radiology
98d
Cleared
Dec 30, 1992
MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
Siemens Medical Solutions USA, Inc.
Radiology
98d
Cleared
Dec 24, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
General Electric Co.
Radiology
261d
Cleared
Dec 24, 1992
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
Hitachi Medical Systems America, Inc.
Radiology
178d
Cleared
Dec 24, 1992
QUADATURE HEAD/NECK/VASCULAR COIL
Medical Advances, Inc.
Radiology
164d
Cleared
Dec 24, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
Siemens Medical Solutions USA, Inc.
Radiology
112d
Cleared
Dec 24, 1992
MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL
Mri Devices Corp.
Radiology
100d
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 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