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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 / K253012

510(k) cleared

AlignRT Plus (8.0)

Vision Rt, Ltd. · Mar 18, 2026 · K253012

FDA cleared the AlignRT Plus (8.0) from Vision Rt, Ltd. on Mar 18, 2026 under K253012, 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 Sep 19, 2025. The decision came 180 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vision Rt, Ltd. has one other decision in the tracker over the last 12 months: K262152 (VS-370CF, VS-370CT).

Questions & Answers

What did FDA clear under K253012?

K253012 is the FDA 510(k) for AlignRT Plus (8.0), submitted by Vision Rt, Ltd.. FDA's decision date was Mar 18, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the AlignRT Plus (8.0)?

Vision Rt, Ltd., based in London, is the applicant of record for K253012.

How long did the K253012 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Mar 18, 2026, 180 days later.

← All decisions in March 2026