Vascular Assist Occlusion Triage (VAOT) (v1.0)— 510(k) K260729

Substantially Equivalent

GuideAI Health

FDA 510(k) clearance K260729 for Vascular Assist Occlusion Triage (VAOT) (v1.0), Substantially Equivalent on 2026-06-18. Applicant: GuideAI Health.

Clearance details

Applicant
GuideAI Health
Product code
Code QAS
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boston, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.