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
769–792 of 1110
Cleared Aug 01, 1994
MODEL GP-252 GENERAL PURPOSE COIL
K935691
Diagnostic Instrument Corp.
Radiology · 245d
Cleared Jul 28, 1994
MERIT
K941408
Philips Medical Systems (Cleveland), Inc.
Radiology · 127d
Cleared Jun 27, 1994
VOLUME NECK COIL FOR THE GYREX V-DIX
K935224
Elscint, Inc.
Radiology · 238d
Cleared Jun 24, 1994
PHILIPS ENDO-CAVITARY MRI COIL
K930193
Philips Medical Systems, Inc.
Radiology · 526d
Cleared Jun 21, 1994
CATCH AND HOLD OPTION FOR INSTASCAN
K934514
Advanced Nmr Systems, Inc.
Radiology · 279d
Cleared Jun 21, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K940364
Medical Advances, Inc.
Radiology · 146d
Cleared Jun 08, 1994
PHASED ARRAY BREAST COIL
K941025
Medical Advances, Inc.
Radiology · 96d
Cleared Jun 03, 1994
MODEL 900GE1500 HEAD/NECK COIL
K940874
Medic, Inc.
Radiology · 98d
Cleared May 23, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K940602
Hitachi Medical Systems America, Inc.
Radiology · 102d
Cleared May 10, 1994
QUADRATURE SMALL EXTREMITY COIL
K935015
Magnetic Research, Inc.
Radiology · 203d
Cleared May 05, 1994
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15
K940514
Medical Advances, Inc.
Radiology · 90d
Cleared Apr 25, 1994
MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY
K934538
Noise Cancellation Technologies
Radiology · 217d
Cleared Mar 30, 1994
VERSION 3 OPERATING SYSTEM SOFTWARE
K935670
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 30, 1994
2D, 3D TOF MR ANGIOGRAPHY
K935671
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 29, 1994
CP BODY ARRAY/ CP SPINE ARRAY COIL
K935627
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 29, 1994
CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS
K935752
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Mar 25, 1994
PHASED ARRAY PELVIC COIL
K935450
Medical Advances, Inc.
Radiology · 133d
Cleared Mar 21, 1994
FAST SPIN ECHO (FSE)
K935369
Resonex, Inc.
Radiology · 137d
Cleared Mar 17, 1994
MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA
K933295
Medic, Inc.
Radiology · 253d
Cleared Mar 17, 1994
MODEL #310GE1500 WRIST COIL
K933296
Medic, Inc.
Radiology · 253d
Cleared Mar 16, 1994
NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM
K935570
Resonex, Inc.
Radiology · 118d
Cleared Mar 16, 1994
MAGNETOM OPEN
K935661
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Mar 16, 1994
FAST SPIN ECHO
K935664
Hitachi Medical Systems America, Inc.
Radiology · 110d
Cleared Mar 04, 1994
VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM
K931460
General Electric Co.
Radiology · 346d