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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 / April 2026 / K253682

510(k) cleared

DeepHealth ProstateAI

Quantib B.V. · Apr 29, 2026 · K253682

FDA cleared the DeepHealth ProstateAI from Quantib B.V. on Apr 29, 2026 under K253682, a traditional 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 21, 2025. The decision came 159 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Quantib B.V. has one other decision in the tracker over the last 12 months: K251527 (Brain WMH).

Questions & Answers

What did FDA clear under K253682?

K253682 is the FDA 510(k) for DeepHealth ProstateAI, submitted by Quantib B.V.. FDA's decision date was Apr 29, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the DeepHealth ProstateAI?

Quantib B.V., based in Rotterdam, is the applicant of record for K253682.

How long did the K253682 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Apr 29, 2026, 159 days later.

← All decisions in April 2026

Sources