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
Mar 28, 1997
ARTOSCAN M
Biosound, Inc.
Radiology
220d
Cleared
Feb 24, 1997
KINEMATIC POSITIONING DEVICES
Philips Medical Systems (Cleveland), Inc.
Radiology
89d
Cleared
Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
Philips Medical Systems (Cleveland), Inc.
Radiology
83d
Cleared
Feb 04, 1997
MRT-35A V9.0
Toshiba America Mri, Inc.
Radiology
78d
Cleared
Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
General Electric Co.
Radiology
80d
Cleared
Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
70d
Cleared
Dec 23, 1996
FLEXART V3.1 SOFTWARE
Toshiba America Mri, Inc.
Radiology
203d
Cleared
Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
183d
Cleared
Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
89d
Cleared
Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
GE Medical Systems
Radiology
85d
Cleared
Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
Siemens Medical Solutions USA, Inc.
Radiology
97d
Cleared
Oct 25, 1996
OPART MRT-600
Toshiba America Mri, Inc.
Radiology
88d
Cleared
Oct 18, 1996
FLEXART TMJ COIL
Toshiba America Mri, Inc.
Radiology
175d
Cleared
Oct 18, 1996
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
GE Medical Systems
Radiology
53d
Cleared
Sep 25, 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
Siemens Medical Solutions USA, Inc.
Radiology
58d
Cleared
Sep 05, 1996
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
Hitachi Medical Systems America, Inc.
Radiology
108d
Cleared
Sep 04, 1996
GYREX V-EP
Elscint, Inc.
Radiology
63d
Cleared
Aug 27, 1996
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
Philips Medical Systems (Cleveland), Inc.
Radiology
88d
Cleared
Aug 14, 1996
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
Hitachi Medical Systems America, Inc.
Radiology
78d
Cleared
Aug 02, 1996
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
Toshiba America Mri, Inc.
Radiology
81d
Cleared
Jul 25, 1996
AIRIS
Hitachi Medical Systems America, Inc.
Radiology
71d
Cleared
Jul 05, 1996
FLEXIBLE PHASED ARRAY SPINE COIL
Philips Medical Systems (Cleveland), Inc.
Radiology
154d
Cleared
Jul 03, 1996
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
Mri Devices Corp.
Radiology
85d
Cleared
Jun 28, 1996
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
Toshiba America Mri, Inc.
Radiology
88d