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THE TAPE

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 / June 2026 / K253050

510(k) cleared

RadOncAI

Informai · Jun 18, 2026 · K253050

FDA cleared the RadOncAI from Informai on Jun 18, 2026 under K253050, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 22, 2025. The decision came 269 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 Informai in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253050?

K253050 is the FDA 510(k) for RadOncAI, submitted by Informai. FDA's decision date was Jun 18, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the RadOncAI?

Informai, based in Houston, TX, is the applicant of record for K253050.

How long did the K253050 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 18, 2026, 269 days later.

← All decisions in June 2026