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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 / K252304

510(k) cleared

syngo.via RT Image Suite VC10

Varian Medical Systems, Inc. · Mar 18, 2026 · K252304

FDA cleared the syngo.via RT Image Suite VC10 from Varian Medical Systems, Inc. on Mar 18, 2026 under K252304, 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 Jul 24, 2025. The decision came 237 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)), K260750 (Virtual Cone (1.0)), K253026 (Respiratory Gating for Scanners (2.1)).

Questions & Answers

What did FDA clear under K252304?

K252304 is the FDA 510(k) for syngo.via RT Image Suite VC10, submitted by Varian Medical Systems, Inc.. FDA's decision date was Mar 18, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the syngo.via RT Image Suite VC10?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K252304.

How long did the K252304 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Mar 18, 2026, 237 days later.

← All decisions in March 2026