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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 / K251710

510(k) cleared

Mobile X-ray unit (!M1)

Solutions For Tomorrow AB · Oct 24, 2025 · K251710

FDA cleared the Mobile X-ray unit (!M1) from Solutions For Tomorrow AB on Oct 24, 2025 under K251710, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 3, 2025. The decision came 143 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 Solutions For Tomorrow AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251710?

K251710 is the FDA 510(k) for Mobile X-ray unit (!M1), submitted by Solutions For Tomorrow AB. FDA's decision date was Oct 24, 2025, under product code IZL (System, X-Ray, Mobile).

Who makes the Mobile X-ray unit (!M1)?

Solutions For Tomorrow AB, based in Väckelsång, is the applicant of record for K251710.

How long did the K251710 review take?

FDA received the submission on Jun 3, 2025 and issued its decision on Oct 24, 2025, 143 days later.

← All decisions in October 2025