a2z-Unified-Triage— 510(k) K252366

Substantially Equivalent

A2z Radiology Ai, Inc.

FDA 510(k) clearance K252366 for a2z-Unified-Triage, Substantially Equivalent on 2025-11-24. Applicant: A2z Radiology Ai, Inc.. Device class: 2.

Clearance details

Applicant
A2z Radiology Ai, Inc.
Product code
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
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