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
817–840 of 1104
Cleared Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 04, 1991
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
K914114
Resonex, Inc.
Radiology · 82d
Cleared Nov 27, 1991
MRT-150A
K914012
Toshiba America Mri, Inc.
Radiology · 79d
Cleared Nov 27, 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
K914535
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 27, 1991
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
K914536
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 25, 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
K913869
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 22, 1991
PHILIPS RIGID VOLUME COILS
K911872
Philips Medical Systems, Inc.
Radiology · 210d
Cleared Nov 22, 1991
MRH-500
K911993
Hitachi Medical Systems America, Inc.
Radiology · 199d
Cleared Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
K914263
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Nov 01, 1991
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
K913325
Resonex, Inc.
Radiology · 99d
Cleared Nov 01, 1991
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
K914019
Hitachi Medical Systems America, Inc.
Radiology · 53d
Cleared Oct 30, 1991
SMT-100X
K911975
Shimadzu Medical Systems
Radiology · 180d
Cleared Oct 30, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K913475
GE Medical Systems
Radiology · 86d
Cleared Oct 21, 1991
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT
K913441
Mri Devices Corp.
Radiology · 80d
Cleared Sep 30, 1991
INSTRUMENTARIUM MEGA4
K912963
Instrumentarium Imaging, Inc.
Radiology · 84d
Cleared Sep 27, 1991
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM
K912539
GE Medical Systems
Radiology · 109d
Cleared Sep 19, 1991
VISTA HPQ SYSTEM
K913534
Philips Medical Systems (Cleveland), Inc.
Radiology · 41d
Cleared Sep 11, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY
K913563
Siemens Medical Solutions USA, Inc.
Radiology · 33d
Cleared Sep 10, 1991
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF
K911959
GE Medical Systems
Radiology · 130d
Cleared Sep 06, 1991
GE MR MAX
K912881
GE Medical Systems
Radiology · 67d
Cleared Aug 09, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K912095
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jul 19, 1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K911991
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 03, 1991
COIL FIELD EXTENDER
K911800
Resonex, Inc.
Radiology · 71d
Cleared Jun 28, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY
K911276
Toshiba America Mri, Inc.
Radiology · 95d