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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

A2z Radiology Ai, Inc. has one other decision in the tracker over the last 12 months: K260906 (a2z-Abdo-Triage).

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

Sources