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
May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
Hitachi Medical Systems America, Inc.
Radiology
49d
Cleared
May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
Hitachi Medical Systems America, Inc.
Radiology
48d
Cleared
May 09, 1991
POWER SCAN 1000
Webb Research, Inc.
Radiology
72d
Cleared
Apr 23, 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
General Electric Co.
Radiology
56d
Cleared
Apr 10, 1991
SMT-50X
Shimadzu Medical Systems
Radiology
114d
Cleared
Apr 08, 1991
10 ADJUSTABLE BELT COIL
Resonex, Inc.
Radiology
76d
Cleared
Mar 25, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
Toshiba America Mri, Inc.
Radiology
67d
Cleared
Mar 25, 1991
MAGNETOM 42 SP AND 63 SP
Siemens Medical Solutions USA, Inc.
Radiology
48d
Cleared
Mar 19, 1991
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
Medical Advances, Inc.
Radiology
42d
Cleared
Mar 19, 1991
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
Medical Advances, Inc.
Radiology
42d
Cleared
Mar 08, 1991
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
Philips Medical Systems, Inc.
Radiology
85d
Cleared
Mar 07, 1991
ANTERIOR NECK CONTOUR COIL
Magnetic Research, Inc.
Radiology
87d
Cleared
Feb 25, 1991
MRP -5000(1): VERSION 2.0 SOFTWARE
Summit World Trade Corp.
Radiology
56d
Cleared
Feb 25, 1991
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
Summit World Trade Corp.
Radiology
56d
Cleared
Feb 19, 1991
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
Summit World Trade Corp.
Radiology
50d
Cleared
Feb 19, 1991
MRP-7000: SUPPLEMENTAL R/F COILS
Summit World Trade Corp.
Radiology
50d
Cleared
Feb 11, 1991
MAGNETOM SP/AS (ACTIVELY SHIELDED)
Siemens Medical Solutions USA, Inc.
Radiology
74d
Cleared
Feb 01, 1991
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Feb 01, 1991
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION
Medical Advances, Inc.
Radiology
45d
Cleared
Jan 24, 1991
VISTA HPQ SYSTEM
Philips Medical Systems (Cleveland), Inc.
Radiology
62d
Cleared
Jan 11, 1991
MODEL 3100-21: QUADRATURE SPINE COIL
Medical Advances, Inc.
Radiology
59d
Cleared
Jan 08, 1991
MODEL 3100-64: QUADRATURE SPINE COIL
Medical Advances, Inc.
Radiology
56d
Cleared
Jan 02, 1991
VISTAR
Philips Medical Systems (Cleveland), Inc.
Radiology
54d
Cleared
Dec 21, 1990
MRT35-SP
Toshiba America Mri, Inc.
Radiology
87d