FDA AI Clearance Tracker/K260729
Radiology · 510(k)
Vascular Assist Occlusion Triage (VAOT) (v1.0)
GuideAI Health
- Device
- Vascular Assist Occlusion Triage (VAOT) (v1.0)
- Company
- GuideAI Health
- Submission number
- K260729
- Pathway
- 510(k)
- Decision date
- Jun 18, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- QAS
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.