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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 / K253421

510(k) cleared

Perfusion Measurement Platform v1

Quantified Imaging Limited · Jun 22, 2026 · K253421

FDA cleared the Perfusion Measurement Platform v1 from Quantified Imaging Limited on Jun 22, 2026 under K253421, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 1, 2025. The decision came 264 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 Quantified Imaging Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253421?

K253421 is the FDA 510(k) for Perfusion Measurement Platform v1, submitted by Quantified Imaging Limited. FDA's decision date was Jun 22, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Perfusion Measurement Platform v1?

Quantified Imaging Limited, based in London, is the applicant of record for K253421.

How long did the K253421 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Jun 22, 2026, 264 days later.

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