K260729

Vascular Assist Occlusion Triage (VAOT) (v1.0)

510(k) number
K260729
Device name
Vascular Assist Occlusion Triage (VAOT) (v1.0)
Applicant
GuideAI Health MA · US
Product code
QAS — Radiological Computer-Assisted Triage And Notificati
Decision date
2026-06-18
Date received
2026-03-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K260729.pdf
Official FDA record: K260729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.