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
Feb 14, 1992
GYREX 2T-DLX
Elscint, Inc.
Radiology
63d
Cleared
Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
Elscint, Inc.
Radiology
49d
Cleared
Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
General Electric Co.
Radiology
157d
Cleared
Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
Siemens Medical Solutions USA, Inc.
Radiology
55d
Cleared
Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
General Electric Co.
Radiology
127d
Cleared
Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
Siemens Medical Solutions USA, Inc.
Radiology
44d
Cleared
Nov 27, 1991
MRT-150A
Toshiba America Mri, Inc.
Radiology
79d
Cleared
Nov 27, 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
Medical Advances, Inc.
Radiology
47d
Cleared
Nov 27, 1991
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
Medical Advances, Inc.
Radiology
47d
Cleared
Nov 25, 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
89d
Cleared
Nov 22, 1991
PHILIPS RIGID VOLUME COILS
Philips Medical Systems, Inc.
Radiology
210d
Cleared
Nov 22, 1991
MRH-500
Hitachi Medical Systems America, Inc.
Radiology
199d
Cleared
Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
Hitachi Medical Systems America, Inc.
Radiology
60d
Cleared
Nov 01, 1991
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
Hitachi Medical Systems America, Inc.
Radiology
53d
Cleared
Oct 30, 1991
SMT-100X
Shimadzu Medical Systems
Radiology
180d
Cleared
Oct 30, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
GE Medical Systems
Radiology
86d
Cleared
Oct 21, 1991
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT
Mri Devices Corp.
Radiology
80d
Cleared
Sep 27, 1991
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM
GE Medical Systems
Radiology
109d
Cleared
Sep 19, 1991
VISTA HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
41d
Cleared
Sep 11, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY
Siemens Medical Solutions USA, Inc.
Radiology
33d
Cleared
Sep 10, 1991
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF
GE Medical Systems
Radiology
130d
Cleared
Sep 06, 1991
GE MR MAX
GE Medical Systems
Radiology
67d
Cleared
Aug 09, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Siemens Medical Solutions USA, Inc.
Radiology
88d
Cleared
Jul 19, 1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Siemens Medical Solutions USA, Inc.
Radiology
74d