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
745–768 of 1110
Cleared Dec 23, 1994
SUPERSENSOR MRI COIL
K941582
Superconductor Technologies, Inc.
Radiology · 267d
Cleared Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112
GE Medical Systems
Radiology · 121d
Cleared Dec 15, 1994
MERIT (O.1T MR SYSTEM)
K943415
Philips Medical Systems (Cleveland), Inc.
Radiology · 153d
Cleared Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799
Hitachi Medical Systems America, Inc.
Radiology · 128d
Cleared Dec 08, 1994
MODEL #300TO3500 SHOULDER COIL
K942874
Medic, Inc.
Radiology · 174d
Cleared Dec 02, 1994
MODEL #700TO3500 NECK/ABDOMINAL COIL
K942873
Medic, Inc.
Radiology · 168d
Cleared Dec 02, 1994
MODEL #900TO3500 HEAD/NECK COIL
K942875
Medic, Inc.
Radiology · 168d
Cleared Nov 29, 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320
Elscint, Inc.
Radiology · 141d
Cleared Nov 22, 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
K940534
Philips Medical Systems, Inc.
Radiology · 288d
Cleared Nov 07, 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541
Siemens Medical Solutions USA, Inc.
Radiology · 273d
Cleared Oct 14, 1994
MRT-150A
K943021
Toshiba America Mri, Inc.
Radiology · 112d
Cleared Sep 30, 1994
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM
K942953
Otsuka Electronics USA, Inc.
Radiology · 100d
Cleared Sep 23, 1994
QUAD PELVIS COIL
K943321
Hitachi Medical Systems America, Inc.
Radiology · 74d
Cleared Sep 21, 1994
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1
K942776
Otsuka Electronics USA, Inc.
Radiology · 100d
Cleared Sep 16, 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
K934987
Elscint, Inc.
Radiology · 333d
Cleared Sep 16, 1994
MODEL #310T03500 WRIST COIL
K942355
Medic, Inc.
Radiology · 122d
Cleared Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K942560
Hitachi Medical Systems America, Inc.
Radiology · 101d
Cleared Sep 02, 1994
MAGNA SL
K940894
Magna-Lab, Inc.
Radiology · 190d
Cleared Sep 02, 1994
MRT-150A SHOULDER COIL
K942609
Toshiba America Mri, Inc.
Radiology · 92d
Cleared Aug 25, 1994
EDGE
K941996
Philips Medical Systems (Cleveland), Inc.
Radiology · 122d
Cleared Aug 24, 1994
GYREX 2T-SGR
K935549
Elscint, Inc.
Radiology · 280d
Cleared Aug 23, 1994
ACCESS
K940796
Toshiba America Mri, Inc.
Radiology · 182d
Cleared Aug 22, 1994
DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL
K934318
Diagnostic Instrument Corp.
Radiology · 355d
Cleared Aug 12, 1994
SLICES
K941812
Microsignal Corp.
Radiology · 122d