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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K252366

510(k) cleared

a2z-Unified-Triage

A2z Radiology Ai, Inc. · Nov 24, 2025 · K252366

FDA cleared the a2z-Unified-Triage from A2z Radiology Ai, Inc. on Nov 24, 2025 under K252366, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 30, 2025. The decision came 117 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for A2z Radiology Ai, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252366?

K252366 is the FDA 510(k) for a2z-Unified-Triage, submitted by A2z Radiology Ai, Inc.. FDA's decision date was Nov 24, 2025, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the a2z-Unified-Triage?

A2z Radiology Ai, Inc., based in Boston, MA, is the applicant of record for K252366.

How long did the K252366 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Nov 24, 2025, 117 days later.

← All decisions in November 2025