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..

1110
Total
1110
Cleared
110d
Avg days
1988
Since
1110 devices
937–960 of 1110
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 16, 1991
H.I.STANDARD CALIBRE UPGRADE
K911746
Health Images, Inc.
Radiology · 120d
Cleared Aug 13, 1991
COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM
K912410
Reality Imaging Corp.
Radiology · 74d
Cleared Aug 09, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K912095
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jul 26, 1991
ULTIMATE 3000
K910839
Fonar Corp.
Radiology · 149d
Cleared Jul 19, 1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K911991
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 15, 1991
VIEWNET
K905578
Imagenet
Radiology · 215d
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
Cleared Jun 28, 1991
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K911806
General Electric Co.
Radiology · 66d
Cleared Jun 21, 1991
RIGID ENDOSCOPE
K911348
Bruel & Kjaer
Radiology · 86d
Cleared Jun 21, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
K911495
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jun 20, 1991
RX-5000 MRI SYSTEM
K911892
Resonex, Inc.
Radiology · 55d
Cleared Jun 07, 1991
VISTA HPQ SYSTEM
K910715
Philips Medical Systems (Cleveland), Inc.
Radiology · 107d