FDA 510(k)

a2z-Unified-Triage

K-Number: K252366 · 2025-11-24

Decision Date2025-11-24

Product CodeQAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

a2z-Unified-Triage is the device name listed in this FDA 510(k) record. The listed applicant is A2z Radiology Ai, Inc.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K252366. 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 a2z-Unified-Triage?

a2z-Unified-Triage is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is A2z Radiology Ai, Inc.. The 510(k) number is K252366.

When did a2z-Unified-Triage receive FDA 510(k) clearance?

a2z-Unified-Triage received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252366.

Who is the listed applicant for a2z-Unified-Triage?

The FDA 510(k) record lists A2z Radiology Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for a2z-Unified-Triage?

The FDA product code for a2z-Unified-Triage is QAS.

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)iSchemaview K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health K261317BriefCase-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.

Official Source

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