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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 / K253111

510(k) cleared

Aeka Imaging

Good Methods Global, Inc. · Mar 13, 2026 · K253111

FDA cleared the Aeka Imaging from Good Methods Global, Inc. on Mar 13, 2026 under K253111, 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 Sep 24, 2025. The decision came 170 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 Good Methods Global, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253111?

K253111 is the FDA 510(k) for Aeka Imaging, submitted by Good Methods Global, Inc.. FDA's decision date was Mar 13, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Aeka Imaging?

Good Methods Global, Inc., based in Celebration, FL, is the applicant of record for K253111.

How long did the K253111 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Mar 13, 2026, 170 days later.

← All decisions in March 2026