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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 / March 2026 / K252249

510(k) cleared

Extremity CT Imaging System

Mars Bioimaging , Ltd. · Mar 13, 2026 · K252249

FDA cleared the Extremity CT Imaging System from Mars Bioimaging , Ltd. on Mar 13, 2026 under K252249, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 18, 2025. The decision came 238 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 Mars Bioimaging , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252249?

K252249 is the FDA 510(k) for Extremity CT Imaging System, submitted by Mars Bioimaging , Ltd.. FDA's decision date was Mar 13, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Extremity CT Imaging System?

Mars Bioimaging , Ltd., based in Christchurch, is the applicant of record for K252249.

How long did the K252249 review take?

FDA received the submission on Jul 18, 2025 and issued its decision on Mar 13, 2026, 238 days later.

← All decisions in March 2026