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The Tracker / September 2026 / K260906

510(k) cleared

a2z-Abdo-Triage

A2z Radiology Ai, Inc. · Sep 16, 2026 · K260906

FDA cleared the a2z-Abdo-Triage from A2z Radiology Ai, Inc. on Sep 16, 2026 under K260906, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 19, 2026. The decision came 181 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

A2z Radiology Ai, Inc. has one other decision in the tracker over the last 12 months: K252366 (a2z-Unified-Triage).

Questions & Answers

What did FDA clear under K260906?

K260906 is the FDA 510(k) for a2z-Abdo-Triage, submitted by A2z Radiology Ai, Inc.. FDA's decision date was Sep 16, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the a2z-Abdo-Triage?

A2z Radiology Ai, Inc., based in Boston, MA, is the applicant of record for K260906.

How long did the K260906 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Sep 16, 2026, 181 days later.

← All decisions in September 2026

Sources