Radiology · 510(k) · 2025
a2z-Unified-Triage
A2z Radiology Ai, Inc.. Cleared by FDA on 24 November 2025 under submission K252366, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K252366
- Device. a2z-Unified-TriageDEVICE
- Company. A2z Radiology Ai, Inc.COMPANY
- Decision. 24 November 2025, 510(k), substantially equivalent (traditional review); received 30 July 2025DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application /submission number, if it is known. This K252366 ? textbox will be left blank for original applications /submissions . Please provide the device trade name(s). ? a2z-Unified-Triage Please provide your Indications for Use below. ? 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 […]
The product code's definition, from FDA's classification record. 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 .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.