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
Jun 21, 1996
ECG MONITOR MODEL DS-3130/3140
Hitachi Medical Systems America, Inc.
Radiology
88d
Cleared
Jun 19, 1996
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
90d
Cleared
Jun 14, 1996
VISART
Toshiba America Medical Systems, In.C
Radiology
87d
Cleared
Jun 10, 1996
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
199d
Cleared
May 29, 1996
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
Medrad, Inc.
Radiology
85d
Cleared
May 29, 1996
MOVABLE ADD-ON COUCH FOR OUTLOOK
Philips Medical Systems (Cleveland), Inc.
Radiology
79d
Cleared
Apr 19, 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
Philips Medical Systems (Cleveland), Inc.
Radiology
88d
Cleared
Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
Radiology
207d
Cleared
Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
Radiology
207d
Cleared
Mar 29, 1996
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
94d
Cleared
Mar 05, 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
Radiology
49d
Cleared
Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
Philips Medical Systems (Cleveland), Inc.
Radiology
100d
Cleared
Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
Philips Medical Systems North America, Inc.
Radiology
382d
Cleared
Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
GE Medical Systems
Radiology
541d
Cleared
Nov 24, 1995
GYREX PRIVILEGE
Elscint, Inc.
Radiology
88d
Cleared
Nov 14, 1995
CLINICAL PROTON SPECTROSCOPY OPTION
Siemens Medical Solutions USA, Inc.
Radiology
218d
Cleared
Nov 14, 1995
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
General Electric Co.
Radiology
57d
Cleared
Oct 23, 1995
IRIS BILATERAL TMJ
Hitachi Medical Systems America, Inc.
Radiology
104d
Cleared
Oct 17, 1995
QD BILATERAL BREAST COIL
Hitachi Medical Systems America, Inc.
Radiology
96d
Cleared
Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
Radiology
332d
Cleared
Sep 19, 1995
GYRES 2T PRESTIGE
Elscint, Inc.
Radiology
298d
Cleared
Sep 18, 1995
OUTLOOK
Philips Medical Systems (Cleveland), Inc.
Radiology
293d
Cleared
Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Hitachi Medical Systems America, Inc.
Radiology
25d
Cleared
Aug 23, 1995
MAGNETOM VISION (PROJECT 016)
Siemens Medical Solutions USA, Inc.
Radiology
271d