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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 / K251964

510(k) cleared

Mimics Thoracic Planner

Materialise NV · Mar 12, 2026 · K251964

FDA cleared the Mimics Thoracic Planner from Materialise NV on Mar 12, 2026 under K251964, 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 Jun 26, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Materialise NV has 3 other decisions in the tracker over the last 12 months: K260802 (Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner), K253308 (Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models), K253793 (Materialise TKA Guide System).

Questions & Answers

What did FDA clear under K251964?

K251964 is the FDA 510(k) for Mimics Thoracic Planner, submitted by Materialise NV. FDA's decision date was Mar 12, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Mimics Thoracic Planner?

Materialise NV, based in Leuven, is the applicant of record for K251964.

How long did the K251964 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Mar 12, 2026, 259 days later.

← All decisions in March 2026