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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
625–648 of 1101
Cleared May 21, 1993
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K924605
General Electric Co.
Radiology · 252d
Cleared May 19, 1993
MRINNERVU ENDORECTAL PROSTATE COIL
K925029
Medrad, Inc.
Radiology · 226d
Cleared Apr 27, 1993
PHILIPS GYROVIEW HR - RELEASE 2
K923944
Philips Medical Systems North America, Inc.
Radiology · 265d
Cleared Apr 27, 1993
MRT-50A SUPER
K924808
Toshiba America Mri, Inc.
Radiology · 215d
Cleared Apr 27, 1993
MRT-150A, QD SPINE COIL
K926171
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Mar 18, 1993
FAST SPIN ECHO MEASURING FUNCTION
K926397
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Mar 16, 1993
SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM
K923984
Shimadzu Medical Systems
Radiology · 221d
Cleared Feb 12, 1993
2D TOF ANGIOGRAHY MEASURING FUNCTION
K925009
Hitachi Medical Systems America, Inc.
Radiology · 135d
Cleared Feb 02, 1993
VISTA HP/HPQ SYSTEM
K925845
Philips Medical Systems (Cleveland), Inc.
Radiology · 76d
Cleared Jan 15, 1993
SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST
K924489
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Jan 15, 1993
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
K925107
Shimadzu Medical Systems
Radiology · 98d
Cleared Dec 30, 1992
MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
K924756
Siemens Medical Solutions USA, Inc.
Radiology · 98d
Cleared Dec 24, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K921653
General Electric Co.
Radiology · 261d
Cleared Dec 24, 1992
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
K923140
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Dec 24, 1992
QUADATURE HEAD/NECK/VASCULAR COIL
K923423
Medical Advances, Inc.
Radiology · 164d
Cleared Dec 24, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K924479
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Dec 24, 1992
MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL
K924653
Mri Devices Corp.
Radiology · 100d
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 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