# K252366: a2z-Unified-Triage

- Pathway: 510(k) (Traditional)
- Applicant: A2z Radiology Ai, Inc.
- Decided: Nov 24, 2025 after 117 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: 4 generations back to DEN170073 (2018). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223240: Annalise Enterprise CTB Triage Trauma, Annalise-Ai Pty, Ltd. (2023) Summary page 5.

## Most influential descendants
- K260906: a2z-Abdo-Triage (2026), 0 descendants of its own

## Indications for use
a2z-Unified-Triage is a radiological computer-aided triage and notification software indicated for use in the analysis of abdominal/pelvic CT images 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 7 specified abdominopelvic findings: Acute Cholecystitis, Acute Pancreatitis, Unruptured Abdominal Aortic Aneurysm, Acute Diverticulitis, Free Air, Hydronephrosis, and Small Bowel Obstruction. These findings are intended to be used together as one device. The device supports both cloud-based and on-premises deployment, with integration either directly with healthcare facility systems or through third-party healthcare technology platforms. a2z-Unified-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 primary diagnosis 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-Unified-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 resoonsible for viewinQ full imaQes per the standard of care.

Source page: https://510kreport.com/device/K252366
Methodology: https://510kreport.com/methodology