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510(k) Data Aggregation
K Number
K131660Device Name
SMART (SMART-D, SMART-DX)
Manufacturer
BTS SPA
Date Cleared
2014-04-17
(315 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
BTS SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.
Device Description
SMART-D is a motion capture and analysis system. It is based on optoelectronic technology and uses passive reflective markers, infrared cameras and strobes.
SMART-D executes the three-dimensional reconstruction of trajectories of a certain number of small reflective markers on the body to be analyzed.
Using a set of cameras placed all around the volume where the action is performed, the system acquires the movement of the subject; cameras position is computed after a calibration step.
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