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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 / K260750

510(k) cleared

Virtual Cone (1.0)

Varian Medical Systems, Inc. · Jul 8, 2026 · K260750

FDA cleared the Virtual Cone (1.0) from Varian Medical Systems, Inc. on Jul 8, 2026 under K260750, 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 Mar 6, 2026. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Varian Medical Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K261856 (Halcyon, Ethos Radiotherapy System (5.0)), K261306 (AI Contouring (VA10A)), K253026 (Respiratory Gating for Scanners (2.1)), K252717 (MAASTRO Rectal Applicator Set).

Questions & Answers

What did FDA clear under K260750?

K260750 is the FDA 510(k) for Virtual Cone (1.0), submitted by Varian Medical Systems, Inc.. FDA's decision date was Jul 8, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the Virtual Cone (1.0)?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K260750.

How long did the K260750 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on Jul 8, 2026, 124 days later.

← All decisions in July 2026