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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 / November 2025 / K252884

510(k) cleared

Guided Aarhus Applicator Set

Varian Medical Systems · Nov 19, 2025 · K252884

FDA cleared the Guided Aarhus Applicator Set from Varian Medical Systems on Nov 19, 2025 under K252884, a traditional 510(k). The device falls under product code JAQ, System, Applicator, Radionuclide, Remote-Controlled, regulated at 21 CFR 892.5700 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 10, 2025. The decision came 70 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)), K261306 (AI Contouring (VA10A)), K260750 (Virtual Cone (1.0)), K253026 (Respiratory Gating for Scanners (2.1)).

Questions & Answers

What did FDA clear under K252884?

K252884 is the FDA 510(k) for Guided Aarhus Applicator Set, submitted by Varian Medical Systems. FDA's decision date was Nov 19, 2025, under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled).

Who makes the Guided Aarhus Applicator Set?

Varian Medical Systems, based in Palo Alto, CA, is the applicant of record for K252884.

How long did the K252884 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Nov 19, 2025, 70 days later.

← All decisions in November 2025