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FDA 510(k)

Vascular Assist Occlusion Triage (VAOT) (v1.0)

K-Number: K260729 · 2026-06-18

ApplicantGuideAI Health
Decision Date2026-06-18
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vascular Assist Occlusion Triage (VAOT) (v1.0) is the device name listed in this FDA 510(k) record. The listed applicant is GuideAI Health. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260729. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vascular Assist Occlusion Triage (VAOT) (v1.0)?

Vascular Assist Occlusion Triage (VAOT) (v1.0) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is GuideAI Health. The 510(k) number is K260729.

When did Vascular Assist Occlusion Triage (VAOT) (v1.0) receive FDA 510(k) clearance?

Vascular Assist Occlusion Triage (VAOT) (v1.0) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260729.

Who is the listed applicant for Vascular Assist Occlusion Triage (VAOT) (v1.0)?

The FDA 510(k) record lists GuideAI Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vascular Assist Occlusion Triage (VAOT) (v1.0)?

The FDA product code for Vascular Assist Occlusion Triage (VAOT) (v1.0) is QAS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentNOT_YET_RECRUITING

Related Devices (Code: QAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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