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 / August 2026 / K261856

510(k) cleared

Halcyon, Ethos Radiotherapy System (5.0)

Varian Medical Systems, Inc. · Aug 3, 2026 · K261856

FDA cleared the Halcyon, Ethos Radiotherapy System (5.0) from Varian Medical Systems, Inc. on Aug 3, 2026 under K261856, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 4, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Varian Medical Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K261306 (AI Contouring (VA10A)), K260750 (Virtual Cone (1.0)), K253026 (Respiratory Gating for Scanners (2.1)), K252717 (MAASTRO Rectal Applicator Set).

Questions & Answers

What did FDA clear under K261856?

K261856 is the FDA 510(k) for Halcyon, Ethos Radiotherapy System (5.0), submitted by Varian Medical Systems, Inc.. FDA's decision date was Aug 3, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the Halcyon, Ethos Radiotherapy System (5.0)?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K261856.

How long did the K261856 review take?

FDA received the submission on Jun 4, 2026 and issued its decision on Aug 3, 2026, 60 days later.

← All decisions in August 2026