EmergencyAI / InformaticsDevices & AI clearances

FDA Clears GuideAI Health’s AI-Powered Vascular Occlusion Triage Software

FDA 510(k) — Radiology devicesJun 18

FDA 510(k) clears GuideAI Health's Vascular Assist Occlusion Triage (VAOT), an AI-powered radiology tool for detecting vascular occlusion on imaging (product code QAS).

  • VAOT is a computer-assisted triage software cleared under FDA product code QAS (radiological CAD).
  • The clearance summary does not report clinical performance metrics, intended imaging modality, or anatomical region.
  • Device clearance does not imply prospective validation or proven clinical impact.
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Automated summary

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