FDA.report

510(k) K252366

Device
a2z-Unified-Triage
Applicant
A2z Radiology Ai, Inc.
510(k) number
K252366
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-24
Date received
2025-07-30
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Samir Rajpurkar
Address
292 Newbury St. Unit 235 Boston MA US 02115 02115

FDA Registration Numbers

Source Documents

510(k) summary PDF

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