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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 / December 2025 / K252863

510(k) cleared

ClearCalc Model RADCA V2.6

Radformation, Inc. · Dec 19, 2025 · K252863

FDA cleared the ClearCalc Model RADCA V2.6 from Radformation, Inc. on Dec 19, 2025 under K252863, 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 9, 2025. The decision came 101 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Radformation, Inc. has 4 other decisions in the tracker over the last 12 months: K262452 (AutoContour (RADAC V6)), K253962 (ClearCheck (RADCC V2.7)), K260509 (AutoContour (RADAC V5)), K252988 (ChartCheck (RADCH V1.6)).

Questions & Answers

What did FDA clear under K252863?

K252863 is the FDA 510(k) for ClearCalc Model RADCA V2.6, submitted by Radformation, Inc.. FDA's decision date was Dec 19, 2025, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the ClearCalc Model RADCA V2.6?

Radformation, Inc., based in New York, NY, is the applicant of record for K252863.

How long did the K252863 review take?

FDA received the submission on Sep 9, 2025 and issued its decision on Dec 19, 2025, 101 days later.

← All decisions in December 2025

Sources