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510(k) Data Aggregation
K Number
K962377Device Name
3D-SPINE
Manufacturer
SKILL TECHNOLOGIES, INC.
Date Cleared
1996-09-03
(75 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Applicant Name (Manufacturer) :
SKILL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.
Device Description
3D-SPINE™ has been developed by Skill Technologies, Inc. as a motion measuring device. 3D-SPINE™ is a real-time three-dimensional motion analysis system that tracks, quantifies, displays and documents the motion of the spine, dynamically, accurately, instantaneously and in three-dimensions. The dynamic tests performed are; extension/flexion, lateral bending and rotation, of the cervical, thoracic, thoracolumbar and lumbar spine.
It has been designed to measure and monitor the three-dimensional angular movement of the human spine. It uses a transmitter to set up a low frequency electromagnetic field, up to a radius of 5 feet from the transmitter. Passive receivers, when brought into range of the transmitter will detect the orientation of the field and the field strength. The receivers will then report x, y and z coordinates, and pitch, yaw and roll angles at a rate of 60 samples per second to a PC computer then displays the information in the form of 3D models of the head and spine and the anqular data in the form of graphs and tables.
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