# K260906: a2z-Abdo-Triage

- Pathway: 510(k) (Traditional)
- Applicant: A2z Radiology Ai, Inc.
- Decided: Sep 16, 2026 after 181 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252366: a2z-Unified-Triage, A2z Radiology Ai, Inc. (2025) Summary page 6.

## Indications for use
a2z-Abdo-Triage is a radiological computer-aided triage and notification software indicated for use in the analysis of abdominopelvic CT images acquired with or without intravenous contrast in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of the 10 specified findings: • Obstructing ureteral stone • Hydroureter • Retroperitoneal hematoma • Large volume ascites • Acute appendicitis • Intraabdominopelvic abscess • Hemoperitoneum or complex free fluid • Splenic traumatic injury • Hepatic traumatic injury • Renal traumatic injury These findings are intended to be used together as one device. a2z-Abdo-Triage uses an artificial intelligence algorithm to analyze images and flag cases with detected findings in parallel to the ongoing standard of care image interpretation. The device provides analysis results that enable client systems to generate notifications for cases with suspected findings. These results can include DICOM instance UIDs for key images, which are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of a2z-Abdo-Triage are intended to be used in conjunction with other patient information and based on clinicians' professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.

Source page: https://510kreport.com/device/K260906
Methodology: https://510kreport.com/methodology