# K260729: Vascular Assist Occlusion Triage (VAOT) (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: GuideAI Health
- Decided: Jun 18, 2026 after 104 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170073 (2018). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220709: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 6.

## Indications for use
VAOT is radiological computer-aided triage and notification software indicated for use in the analysis of CTA studies of adult patients. The device is intended to assist hospital networks and trained medical specialists in workflow prioritization by identifying studies with imaging patterns consistent with possible total arterial occlusion within the aorta, common iliac, external iliac, common femoral, superficial femoral, and popliteal arteries. VAOT analyzes CTA images in parallel with the on-going standard-of-care interpretation workflow. When predefined criteria are met, VAOT generates a notification to alert the user that the case may warrant prioritization. Notifications may include compressed preview images provided for informational purposes only and are not intended for diagnostic use. The results of VAOT are not intended for primary diagnosis, screening, disease detection, or patient management decisions. The interpreting clinician remains responsible for viewing the full imaging study according to standard clinical practice. VAOT does not detect, localize, characterize, measure, or diagnose vascular disease and does not alter the original medical images.

Source page: https://510kreport.com/device/K260729
Methodology: https://510kreport.com/methodology