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510(k) Data Aggregation
K Number
K011827Device Name
ORTELIUS 800
Manufacturer
ORTHOSCAN LTD.
Date Cleared
2001-08-28
(77 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Product Code :
KQX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
Device Description
The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.
The Ortelius 800 enables the following features:
- · Spine curve reconstruction based on the points sampled by the Sensor.
- · Automatically calculated spine deformity angles of the primary curve.
- · Indication of the extreme vertebra from which the spine deformity angle was calculated.
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K Number
K971079Device Name
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
Manufacturer
INTERLOGICS, INC.
Date Cleared
1997-07-09
(106 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Product Code :
KQX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The Clinical Analysis protocol requires the subject to perform a series of wrist movements, including wrist flexion/extension and ulnar/radial deviation, each to be performed by the subject at his/her preferred speed. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port.
The goals of the device when performing the Clinical Analysis protocol is to compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations.
Device Description
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port. The W-Tracker does not initiate or control any movement during a test and it does not induce any forces on the subject. It is, therefore, a passive device. The only forces acting on the subject are the negligible inertial forces of the W-Tracker generated by the subject's wrist movements. The device is fail-safe in design to obviate safety concerns for the subject.
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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?
Product Code :
KQX
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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K Number
K961212Device Name
SPINAL TOUCH
Manufacturer
FASSTECH
Date Cleared
1996-06-12
(76 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Product Code :
KQX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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