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..

1101
Total
1101
Cleared
110d
Avg days
1988
Since
1101 devices
553–576 of 1101
Cleared Jan 25, 1995
FLEXART QD BODY COIL
K944662
Toshiba America Mri, Inc.
Radiology · 126d
Cleared Jan 25, 1995
MODEL 405GE-64: PHASED ARRAY TMJ COIL
K944773
Medical Advances, Inc.
Radiology · 120d
Cleared Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
K943800
Hitachi Medical Systems America, Inc.
Radiology · 149d
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 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 23, 1994
QUAD PELVIS COIL
K943321
Hitachi Medical Systems America, Inc.
Radiology · 74d
Cleared Sep 16, 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
K934987
Elscint, Inc.
Radiology · 333d
Cleared Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K942560
Hitachi Medical Systems America, Inc.
Radiology · 101d
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 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
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 May 23, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K940602
Hitachi Medical Systems America, Inc.
Radiology · 102d
Cleared May 05, 1994
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15
K940514
Medical Advances, Inc.
Radiology · 90d