WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / November 2025 / K250963

510(k) cleared

PlanOne 1

Cosylab Jsc, Control System Laboratory · Nov 20, 2025 · K250963

FDA cleared the PlanOne 1 from Cosylab Jsc, Control System Laboratory on Nov 20, 2025 under K250963, 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 31, 2025. The decision came 234 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 Cosylab Jsc, Control System Laboratory in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250963?

K250963 is the FDA 510(k) for PlanOne 1, submitted by Cosylab Jsc, Control System Laboratory. FDA's decision date was Nov 20, 2025, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the PlanOne 1?

Cosylab Jsc, Control System Laboratory, based in Ljubljana, is the applicant of record for K250963.

How long did the K250963 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Nov 20, 2025, 234 days later.

← All decisions in November 2025