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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 / June 2026 / K253969

510(k) cleared

ADAS 3D

Adas3D Medical S.L. · Jun 29, 2026 · K253969

FDA cleared the ADAS 3D from Adas3D Medical S.L. on Jun 29, 2026 under K253969, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 11, 2025. The decision came 200 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 Adas3D Medical S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253969?

K253969 is the FDA 510(k) for ADAS 3D, submitted by Adas3D Medical S.L.. FDA's decision date was Jun 29, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the ADAS 3D?

Adas3D Medical S.L., based in Barcelona, is the applicant of record for K253969.

How long did the K253969 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Jun 29, 2026, 200 days later.

← All decisions in June 2026