a2z-Abdo-Triage— 510(k) K260906
Substantially EquivalentA2z Radiology Ai, Inc.
FDA 510(k) clearance K260906 for a2z-Abdo-Triage, Substantially Equivalent on 2026-09-16. Applicant: A2z Radiology Ai, Inc.. Device class: 2.
Summary
a2z-Abdo-Triage is from A2z Radiology Ai, Inc., filed under product code QAS (Radiological Computer-Assisted Triage And Notification Software). The record doesn't describe its inputs or outputs beyond that code name.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
A2z filed from Boston, Massachusetts. The decision came 181 calendar days after FDA received it (March 19 to September 16, 2026).
Clearance details
- Applicant
- A2z Radiology Ai, Inc.
- Product code
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code QAS
view allMore clearances from A2z Radiology Ai, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.