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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 / September 2025 / K251527

510(k) cleared

Brain WMH

Quantib B.V. · Sep 25, 2025 · K251527

FDA cleared the Brain WMH from Quantib B.V. on Sep 25, 2025 under K251527, 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 May 19, 2025. The decision came 129 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: K253682 (DeepHealth ProstateAI).

Questions & Answers

What did FDA clear under K251527?

K251527 is the FDA 510(k) for Brain WMH, submitted by Quantib B.V.. FDA's decision date was Sep 25, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Brain WMH?

Quantib B.V., based in Rotterdam, is the applicant of record for K251527.

How long did the K251527 review take?

FDA received the submission on May 19, 2025 and issued its decision on Sep 25, 2025, 129 days later.

← All decisions in September 2025

Sources