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THE TAPE

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 / K252086

510(k) cleared

DTX Studio Assist

Nobel Biocare C/O Medicim NV · Nov 17, 2025 · K252086

FDA cleared the DTX Studio Assist from Nobel Biocare C/O Medicim NV on Nov 17, 2025 under K252086, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 2, 2025. The decision came 138 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nobel Biocare C/O Medicim NV has 2 other decisions in the tracker over the last 12 months: K253999 (Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw), K252197 (Nobel Biocare S Series Implants).

Questions & Answers

What did FDA clear under K252086?

K252086 is the FDA 510(k) for DTX Studio Assist, submitted by Nobel Biocare C/O Medicim NV. FDA's decision date was Nov 17, 2025, under product code MYN (Analyzer, Medical Image).

Who makes the DTX Studio Assist?

Nobel Biocare C/O Medicim NV, based in Mechelen, is the applicant of record for K252086.

How long did the K252086 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Nov 17, 2025, 138 days later.

← All decisions in November 2025