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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 / March 2026 / K260509

510(k) cleared

AutoContour (RADAC V5)

Radformation, Inc. · Mar 19, 2026 · K260509

FDA cleared the AutoContour (RADAC V5) from Radformation, Inc. on Mar 19, 2026 under K260509, a special 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 17, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Radformation, Inc. has 4 other decisions in the tracker over the last 12 months: K262452 (AutoContour (RADAC V6)), K253962 (ClearCheck (RADCC V2.7)), K252988 (ChartCheck (RADCH V1.6)), K252863 (ClearCalc Model RADCA V2.6).

Questions & Answers

What did FDA clear under K260509?

K260509 is the FDA 510(k) for AutoContour (RADAC V5), submitted by Radformation, Inc.. FDA's decision date was Mar 19, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the AutoContour (RADAC V5)?

Radformation, Inc., based in New York, NY, is the applicant of record for K260509.

How long did the K260509 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Mar 19, 2026, 30 days later.

← All decisions in March 2026

Sources