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
Nov 17, 1989
GE MR MAX SYSTEM
GE Medical Systems
Radiology
50d
Cleared
Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
Shimadzu Medical Systems
Radiology
172d
Cleared
Oct 30, 1989
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
81d
Cleared
Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
Diasonics, Inc.
Radiology
172d
Cleared
Oct 27, 1989
MODEL 2031 TMJ SURFACE COIL
Medical Advances, Inc.
Radiology
71d
Cleared
Oct 03, 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
Siemens Medical Solutions USA, Inc.
Radiology
67d
Cleared
Sep 07, 1989
ACCESS TM
Diasonics, Inc.
Radiology
76d
Cleared
Aug 11, 1989
GE SIGNA ADVANTAGE
GE Medical Systems
Radiology
98d
Cleared
Aug 09, 1989
MRT-50A MOBILE
Toshiba Medical Systems
Radiology
83d
Cleared
Aug 02, 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
Siemens Medical Solutions USA, Inc.
Radiology
79d
Cleared
Jul 20, 1989
VISION INTEGRATED PERFORMANCE OPTION
Siemens Medical Solutions USA, Inc.
Radiology
65d
Cleared
Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
Philips Medical Systems (Cleveland), Inc.
Radiology
59d
Cleared
Jul 14, 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
Philips Medical Systems (Cleveland), Inc.
Radiology
58d
Cleared
Jun 23, 1989
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
44d
Cleared
Jun 23, 1989
ACCESS TM
Diasonics, Inc.
Radiology
28d
Cleared
Jun 15, 1989
MAGNISCAN 5000 MR SYSTEM
General Electric Co.
Radiology
83d
Cleared
May 11, 1989
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
Diasonics, Inc.
Radiology
55d
Cleared
May 11, 1989
MODEL 2030
Medical Advances, Inc.
Radiology
52d
Cleared
May 11, 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
General Electric Co.
Radiology
37d
Cleared
May 01, 1989
MODEL 4041
Medical Advances, Inc.
Radiology
69d
Cleared
Apr 28, 1989
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Philips Medical Systems North America, Inc.
Radiology
72d
Cleared
Apr 14, 1989
MODEL 3031
Medical Advances, Inc.
Radiology
64d
Cleared
Apr 03, 1989
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
Siemens Medical Solutions USA, Inc.
Radiology
45d
Cleared
Mar 14, 1989
VISTA MR 2055 HP SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
98d