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
Cleared
Jan 25, 1995
FLEXART QD BODY COIL
Toshiba America Mri, Inc.
Radiology
126d
Cleared
Jan 25, 1995
MODEL 405GE-64: PHASED ARRAY TMJ COIL
Medical Advances, Inc.
Radiology
120d
Cleared
Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
Hitachi Medical Systems America, Inc.
Radiology
149d
Cleared
Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
GE Medical Systems
Radiology
121d
Cleared
Dec 15, 1994
MERIT (O.1T MR SYSTEM)
Philips Medical Systems (Cleveland), Inc.
Radiology
153d
Cleared
Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
Radiology
128d
Cleared
Nov 29, 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
Elscint, Inc.
Radiology
141d
Cleared
Nov 22, 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
Philips Medical Systems, Inc.
Radiology
288d
Cleared
Nov 07, 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
Siemens Medical Solutions USA, Inc.
Radiology
273d
Cleared
Oct 14, 1994
MRT-150A
Toshiba America Mri, Inc.
Radiology
112d
Cleared
Sep 23, 1994
QUAD PELVIS COIL
Hitachi Medical Systems America, Inc.
Radiology
74d
Cleared
Sep 16, 1994
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
Elscint, Inc.
Radiology
333d
Cleared
Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Hitachi Medical Systems America, Inc.
Radiology
101d
Cleared
Sep 02, 1994
MRT-150A SHOULDER COIL
Toshiba America Mri, Inc.
Radiology
92d
Cleared
Aug 25, 1994
EDGE
Philips Medical Systems (Cleveland), Inc.
Radiology
122d
Cleared
Aug 24, 1994
GYREX 2T-SGR
Elscint, Inc.
Radiology
280d
Cleared
Aug 23, 1994
ACCESS
Toshiba America Mri, Inc.
Radiology
182d
Cleared
Jul 28, 1994
MERIT
Philips Medical Systems (Cleveland), Inc.
Radiology
127d
Cleared
Jun 27, 1994
VOLUME NECK COIL FOR THE GYREX V-DIX
Elscint, Inc.
Radiology
238d
Cleared
Jun 24, 1994
PHILIPS ENDO-CAVITARY MRI COIL
Philips Medical Systems, Inc.
Radiology
526d
Cleared
Jun 21, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
Medical Advances, Inc.
Radiology
146d
Cleared
Jun 08, 1994
PHASED ARRAY BREAST COIL
Medical Advances, Inc.
Radiology
96d
Cleared
May 23, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
Hitachi Medical Systems America, Inc.
Radiology
102d
Cleared
May 05, 1994
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15
Medical Advances, Inc.
Radiology
90d