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510(k) Data Aggregation
K Number
K171547Device Name
Qualisys Clinical System
Manufacturer
Qualisys AB
Date Cleared
2018-08-02
(433 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
Qualisys AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.
Device Description
The Qualisys Clinical System (QCS) is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.
In order to achieve this, the QCS utilizes data captured from image sensors (motion capture cameras) to triangulate the 3D-position of one or several reflective markers attached to the patient. This is done by two or more cameras calibrated to provide overlapping field of views from multiple angles. QCS produce data with 3 degrees of freedom for each marker, i.e. positional information. Rotational information (e.g. of a limb) may be retrieved from the relative orientation of three or more markers.
The tracking cameras may record images and identify the position of the markers with a high spatial and temporal resolution to generate high performance motion capture of the markers.
The markers are usually attached directly to the skin. The markers are specially designed to reflect the IR-light flashed from the tracking cameras.
In addition, subsystems may be added to record data in synchronization with the tracking cameras to facilitate the analysis, or for pure documentation purposes. The additional subsystems may be any one of, or a combination of: 1) Ordinary video, 2) EMG data and 3) Force plate data.
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