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.
Clearance details
- Applicant
- GuideAI Health
- Product code
- 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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