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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 / July 2026 / K261306

510(k) cleared

AI Contouring (VA10A)

Varian Medical Systems · Jul 10, 2026 · K261306

FDA cleared the AI Contouring (VA10A) from Varian Medical Systems on Jul 10, 2026 under K261306, a traditional 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 Apr 20, 2026. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

Varian Medical Systems has 8 other decisions in the tracker over the last 12 months: K261856 (Halcyon, Ethos Radiotherapy System (5.0)), K260750 (Virtual Cone (1.0)), K253026 (Respiratory Gating for Scanners (2.1)), K252717 (MAASTRO Rectal Applicator Set).

Questions & Answers

What did FDA clear under K261306?

K261306 is the FDA 510(k) for AI Contouring (VA10A), submitted by Varian Medical Systems. FDA's decision date was Jul 10, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the AI Contouring (VA10A)?

Varian Medical Systems, based in Palo Alto, CA, is the applicant of record for K261306.

How long did the K261306 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Jul 10, 2026, 81 days later.

← All decisions in July 2026