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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 / December 2025 / K253844

510(k) cleared

AnyScan 3.0 NM Scanner Family

Mediso Medical Imaging Systems, Ltd. · Dec 30, 2025 · K253844

FDA cleared the AnyScan 3.0 NM Scanner Family from Mediso Medical Imaging Systems, Ltd. on Dec 30, 2025 under K253844, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 2, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mediso Medical Imaging Systems, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253844?

K253844 is the FDA 510(k) for AnyScan 3.0 NM Scanner Family, submitted by Mediso Medical Imaging Systems, Ltd.. FDA's decision date was Dec 30, 2025, under product code KPS (System, Tomography, Computed, Emission).

Who makes the AnyScan 3.0 NM Scanner Family?

Mediso Medical Imaging Systems, Ltd., based in Budapest, is the applicant of record for K253844.

How long did the K253844 review take?

FDA received the submission on Dec 2, 2025 and issued its decision on Dec 30, 2025, 28 days later.

← All decisions in December 2025