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
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 20, 1996
ESTEEM 1.5T MRI SYSTEM
Elscint Mr, Inc.
Radiology
73d
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
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