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
745–768 of 1104
Cleared Jun 18, 1993
MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL
K931008
Mri Devices Corp.
Radiology · 112d
Cleared Jun 08, 1993
MRH-1500
K922846
Hitachi Medical Systems America, Inc.
Radiology · 358d
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 May 19, 1993
INSTRUMENTARIUM MEGA4 HT
K925987
Instrumentarium Imaging, Inc.
Radiology · 175d
Cleared May 17, 1993
INSTRUMENTARIUM MEGA4 HT
K924921
Instrumentarium Imaging, Inc.
Radiology · 234d
Cleared May 03, 1993
INSTRUMENTARIUM MEGA4 HT
K923581
Instrumentarium Imaging, Inc.
Radiology · 287d
Cleared May 03, 1993
INSTRUMENTARIUM MEGA4 HT
K924472
Instrumentarium Imaging, Inc.
Radiology · 243d
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 Jan 12, 1993
3DTOF MRA
K923870
Resonex, Inc.
Radiology · 162d
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