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510(k) K252366

a2z-Unified-Triage by A2z Radiology Ai, Inc. — Product Code QAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2025
Date Received
July 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Computer-Assisted Triage And Notification Software
Device Class
Class II
Regulation Number
892.2080
Review Panel
RA
Submission Type

Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .

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