Company profile

GuideAI Health

GuideAI Health has 1 AI-enabled medical device on the FDA list. The first decision was on June 18, 2026 and the most recent on June 18, 2026 (Vascular Assist Occlusion Triage (VAOT) (v1.0)). Its most common review panel is Radiology (1 device).

1AI devices

2026First decision

2026Latest decision

1Specialties

Timeline

June 18, 2026 · 510(k) K260729Vascular Assist Occlusion Triage (VAOT) (v1.0) · Radiology · QAS