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FDA 510(k)

a2z-Unified-Triage

K-Number: K252366 · 2025-11-24

ApplicantA2z Radiology Ai, Inc.
Decision Date2025-11-24
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

a2z-Unified-Triage is a medical device manufactured by A2z Radiology Ai, Inc.. It received FDA 510(k) clearance on 2025-11-24 under approval 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. It is manufactured by A2z Radiology Ai, Inc.. The 510(k) number is K252366.

When was a2z-Unified-Triage approved by the FDA?

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

What company makes a2z-Unified-Triage?

a2z-Unified-Triage is manufactured by A2z Radiology Ai, Inc..

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

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

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Official Source

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