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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 / May 2026 / K253078

510(k) cleared

ART.1-US

Seetreat Pty, Ltd. · May 14, 2026 · K253078

FDA cleared the ART.1-US from Seetreat Pty, Ltd. on May 14, 2026 under K253078, 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 Sep 23, 2025. The decision came 233 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 Seetreat Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253078?

K253078 is the FDA 510(k) for ART.1-US, submitted by Seetreat Pty, Ltd.. FDA's decision date was May 14, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the ART.1-US?

Seetreat Pty, Ltd., based in Sydney, is the applicant of record for K253078.

How long did the K253078 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on May 14, 2026, 233 days later.

← All decisions in May 2026