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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 / October 2025 / K252199

510(k) cleared

AGFA HealthCare Enterprise Imaging

Agfa Healthcare N.V. · Oct 15, 2025 · K252199

FDA cleared the AGFA HealthCare Enterprise Imaging from Agfa Healthcare N.V. on Oct 15, 2025 under K252199, 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 Jul 14, 2025. The decision came 93 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 Agfa Healthcare N.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252199?

K252199 is the FDA 510(k) for AGFA HealthCare Enterprise Imaging, submitted by Agfa Healthcare N.V.. FDA's decision date was Oct 15, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the AGFA HealthCare Enterprise Imaging?

Agfa Healthcare N.V., based in Mortsel, is the applicant of record for K252199.

How long did the K252199 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Oct 15, 2025, 93 days later.

← All decisions in October 2025