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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 / K252195

510(k) cleared

ARTICOR planner

Artiness S.R.L · Mar 27, 2026 · K252195

FDA cleared the ARTICOR planner from Artiness S.R.L on Mar 27, 2026 under K252195, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 14, 2025. The decision came 256 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 Artiness S.R.L in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252195?

K252195 is the FDA 510(k) for ARTICOR planner, submitted by Artiness S.R.L. FDA's decision date was Mar 27, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the ARTICOR planner?

Artiness S.R.L, based in Milan, is the applicant of record for K252195.

How long did the K252195 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Mar 27, 2026, 256 days later.

← All decisions in March 2026