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510(k) Data Aggregation
K Number
K242726Device Name
Synapsys VHIT
Manufacturer
Inventis S.r.l.
Date Cleared
2025-01-03
(115 days)
Product Code
GWN
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
Inventis S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements.
Device Description
Synapsys VHT (Video Head Impulse Test) allows to assess the vestibular-ocular-reflex (VOR) by measuring, and analyzing eye and head movements. Synapsys VHT does not require the patient to wear goggles, since it consists of a remote camera placed 90 cm from the subject, framing the subject's eyes and head. The device features real-time eyes detection and tracking, thanks to a built-in infrared illuminator hat lights up the subject. Head displacements are retrieved using algorithms that extract motion data from real time images recorded by the camera.
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