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
961–984 of 1110
Cleared May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
K911642
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667
Hitachi Medical Systems America, Inc.
Radiology · 48d
Cleared May 09, 1991
POWER SCAN 1000
K910802
Webb Research, Inc.
Radiology · 72d
Cleared Apr 23, 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817
General Electric Co.
Radiology · 56d
Cleared Apr 10, 1991
SMT-50X
K905634
Shimadzu Medical Systems
Radiology · 114d
Cleared Apr 08, 1991
10 ADJUSTABLE BELT COIL
K910269
Resonex, Inc.
Radiology · 76d
Cleared Mar 25, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
K910220
Toshiba America Mri, Inc.
Radiology · 67d
Cleared Mar 25, 1991
MAGNETOM 42 SP AND 63 SP
K910498
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Mar 19, 1991
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
K910513
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 19, 1991
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
K910514
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 08, 1991
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
K905603
Philips Medical Systems, Inc.
Radiology · 85d
Cleared Mar 07, 1991
ANTERIOR NECK CONTOUR COIL
K905512
Magnetic Research, Inc.
Radiology · 87d
Cleared Feb 25, 1991
MRP -5000(1): VERSION 2.0 SOFTWARE
K905832
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
K905833
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 19, 1991
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
K905834
Summit World Trade Corp.
Radiology · 50d
Cleared Feb 19, 1991
MRP-7000: SUPPLEMENTAL R/F COILS
K905835
Summit World Trade Corp.
Radiology · 50d
Cleared Feb 11, 1991
MAGNETOM SP/AS (ACTIVELY SHIELDED)
K905366
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Feb 01, 1991
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
K905615
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Feb 01, 1991
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION
K905858
Medical Advances, Inc.
Radiology · 45d
Cleared Jan 24, 1991
VISTA HPQ SYSTEM
K905259
Philips Medical Systems (Cleveland), Inc.
Radiology · 62d
Cleared Jan 11, 1991
MODEL 3100-21: QUADRATURE SPINE COIL
K905095
Medical Advances, Inc.
Radiology · 59d
Cleared Jan 08, 1991
MODEL 3100-64: QUADRATURE SPINE COIL
K905104
Medical Advances, Inc.
Radiology · 56d
Cleared Jan 02, 1991
VISTAR
K905070
Philips Medical Systems (Cleveland), Inc.
Radiology · 54d
Cleared Dec 21, 1990
MRT35-SP
K905442
Toshiba America Mri, Inc.
Radiology · 87d