LNH · Class II · 21 CFR 892.1000

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
913–936 of 1110
Cleared Mar 16, 1992
MRI ULTRAVIEW
K915260
A&E Specialty Fabricators
Radiology · 118d
Cleared Mar 16, 1992
16 BIT A/D
K915754
Resonex, Inc.
Radiology · 84d
Cleared Mar 16, 1992
MOS-III
K915873
Sherman Ophthalmic Supplies, Inc.
Radiology · 102d
Cleared Mar 13, 1992
MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
K915657
Bruker Medical Imaging, Inc.
Radiology · 86d
Cleared Mar 06, 1992
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
K920199
Philips Medical Systems (Cleveland), Inc.
Radiology · 51d
Cleared Mar 05, 1992
MODEL 310GE-64: WHOLE VOLUME NECK COIL
K914209
Medical Advances, Inc.
Radiology · 168d
Cleared Mar 05, 1992
MOBILE MRP-7000
K920159
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Feb 27, 1992
INSTRUMENTARIUM MEGA4
K915552
Instrumentarium Imaging, Inc.
Radiology · 78d
Cleared Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
K915579
Elscint, Inc.
Radiology · 67d
Cleared Feb 14, 1992
GYREX 2T-DLX
K915601
Elscint, Inc.
Radiology · 63d
Cleared Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
K915598
Elscint, Inc.
Radiology · 49d
Cleared Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K913673
General Electric Co.
Radiology · 157d
Cleared Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
K915395
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
K913770
General Electric Co.
Radiology · 127d
Cleared Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 04, 1991
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
K914114
Resonex, Inc.
Radiology · 82d
Cleared Nov 29, 1991
MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN
K913463
Bruker Medical Imaging, Inc.
Radiology · 116d
Cleared Nov 27, 1991
MRT-150A
K914012
Toshiba America Mri, Inc.
Radiology · 79d
Cleared Nov 27, 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
K914535
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 27, 1991
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
K914536
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 25, 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
K913869
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 22, 1991
PHILIPS RIGID VOLUME COILS
K911872
Philips Medical Systems, Inc.
Radiology · 210d
Cleared Nov 22, 1991
MRH-500
K911993
Hitachi Medical Systems America, Inc.
Radiology · 199d
Cleared Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
K914263
Hitachi Medical Systems America, Inc.
Radiology · 60d