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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 / September 2025 / K250369

510(k) cleared

Axial3D Insight

Axial Medical Printing Limited · Sep 18, 2025 · K250369

FDA cleared the Axial3D Insight from Axial Medical Printing Limited on Sep 18, 2025 under K250369, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 10, 2025. The decision came 220 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 Axial Medical Printing Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250369?

K250369 is the FDA 510(k) for Axial3D Insight, submitted by Axial Medical Printing Limited. FDA's decision date was Sep 18, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Axial3D Insight?

Axial Medical Printing Limited, based in Belfast, is the applicant of record for K250369.

How long did the K250369 review take?

FDA received the submission on Feb 10, 2025 and issued its decision on Sep 18, 2025, 220 days later.

← All decisions in September 2025