Vascular Assist Occlusion Triage (VAOT) (v1.0)— 510(k) K260729
Substantially EquivalentGuideAI Health
FDA 510(k) clearance K260729 for Vascular Assist Occlusion Triage (VAOT) (v1.0), Substantially Equivalent on 2026-06-18. Applicant: GuideAI Health. Device class: 2.
Summary
GuideAI Health's Vascular Assist Occlusion Triage (VAOT), version 1.0, is filed under QAS, radiological computer-assisted triage and notification software. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
GuideAI Health filed from Boston, Massachusetts. The decision came 104 calendar days after FDA received it (March 6 to June 18, 2026).
Clearance details
- Applicant
- GuideAI Health
- Product code
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code QAS
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