FDA Clears a2z Radiology AI Triage Software for 10 More Abdominal CT Findings

The FDA has cleared a2z-Abdo-Triage, artificial intelligence software from a2z Radiology AI that flags 10 urgent findings on abdominal and pelvic CT scans for priority review by radiologists, Diagnostic Imaging reported on September 22. The agency's 510(k) database lists the clearance as K260906, with a decision date of September 16, 2026.

The submission was received on March 19, 2026, and was found substantially equivalent under the regulation for radiological computer-aided triage and notification software, 21 CFR 892.2080, product codes QAS and QFM. The record shows that a predetermined change control plan was authorized, allowing specified later changes under a plan the FDA reviewed in advance. The applicant is A2z Radiology Ai, Inc., of Boston.

The 10 findings

According to Diagnostic Imaging, the newly cleared findings are:

• acute appendicitis;
• hemoperitoneum or complex free fluid;
• hepatic, renal and splenic traumatic injury;
• hydroureter;
• intraabdominopelvic abscess;
• large volume ascites;
• retroperitoneal injury;
• ureteral stone.

The software can be used on abdominopelvic CT scans taken with or without contrast and works as an adjunct, flagging suspected cases so radiologists can read them sooner, the developer said. Diagnostic Imaging reported that the software has also received breakthrough device designation from the FDA.

"This clearance extends the range of clinically important findings we can flag on CT scans, bringing us closer to our goal of helping teams focus their attention where it is needed," said Samir Rajpurkar, the company's co-founder and chief executive, according to Diagnostic Imaging.

A second product in ten months

The new clearance follows the company's first, for a2z-Unified-Triage. The FDA database shows that product, K252366, was cleared on November 24, 2025, under the same regulation and product codes, also with an authorized change control plan.

That earlier device is designed to flag seven acute conditions in one pass: small bowel obstruction, acute pancreatitis, acute cholecystitis, acute diverticulitis, free air, hydronephrosis and unruptured abdominal aortic aneurysm, Medical Device Developments reported in November 2025. The company said at the time that it was the first single device cleared in the US to triage multiple urgent conditions on abdomen-pelvis CT, and that more than 20 million such scans are performed in the US each year.

"We set out to build a generalist system that could scale across conditions," co-founder Pranav Rajpurkar, an associate professor at Harvard Medical School, said then. Samir Rajpurkar said the company was "not stopping at seven."

Neither the coverage nor the database entry gave performance figures for the new findings or pricing.