510(k) · Cleared
ClearedVascular Assist Occlusion Triage (VAOT) (v1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GuideAI Health · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Jun 18, 2026 as substantially equivalent to K220709 (Aidoc Medical, Ltd., 2022) after a 104-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Jun 18, 2026
- Review
- 104 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN170073 (2018). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 5 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 4 generations backK190072 BriefCaseAidoc Medical, Ltd. · 2019
- 3 generations backK201020 BriefCaseAidoc Medical, Ltd. · 2020
- 2 generations backK203508 BriefCaseAidoc Medical, Ltd. · 2020
- 1 generation backK220709 BriefCaseAidoc Medical, Ltd. · 2022
- This deviceK260729 Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −5 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −4 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| −3 | K201020 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| −2 | K203508 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
| −1 | K220709 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| 0 (this device) | K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAS device
- #1 K203508 BriefCasescore 25.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220709 | BriefCaseSummary page 6…Value Predicate Device Name Briefcase LVO Triage Predicate Device K Number K220709 Product Code QAS Regulation Number… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K220709.
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
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…
Read the full statement (162 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260729: Vascular Assist Occlusion Triage (VAOT) (v1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260729
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026