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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 / August 2026 / K253794

510(k) cleared

Prostate Core

Lucida Medical, Ltd. · Aug 10, 2026 · K253794

FDA cleared the Prostate Core from Lucida Medical, Ltd. on Aug 10, 2026 under K253794, 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 Nov 28, 2025. The decision came 255 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 Lucida Medical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253794?

K253794 is the FDA 510(k) for Prostate Core, submitted by Lucida Medical, Ltd.. FDA's decision date was Aug 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Prostate Core?

Lucida Medical, Ltd., based in Cambridge, is the applicant of record for K253794.

How long did the K253794 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 10, 2026, 255 days later.

← All decisions in August 2026