Radiology · 510(k) · 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
GuideAI Health. Cleared by FDA on 18 June 2026 under submission K260729, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K260729
- Device. Vascular Assist Occlusion Triage (VAOT) (v1.0)DEVICE
- Company. GuideAI HealthCOMPANY
- Decision. 18 June 2026, 510(k), substantially equivalent (traditional review); received 6 March 2026DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsa statement that it is not for primary diagnosis
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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