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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 / K250911

510(k) cleared

MOSkin Radiation Measurement System

Electrogenics Labs, Ltd. · Oct 17, 2025 · K250911

FDA cleared the MOSkin Radiation Measurement System from Electrogenics Labs, Ltd. on Oct 17, 2025 under K250911, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 26, 2025. The decision came 205 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 Electrogenics Labs, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250911?

K250911 is the FDA 510(k) for MOSkin Radiation Measurement System, submitted by Electrogenics Labs, Ltd.. FDA's decision date was Oct 17, 2025, under product code IYE (Accelerator, Linear, Medical).

Who makes the MOSkin Radiation Measurement System?

Electrogenics Labs, Ltd., based in North Sydney, is the applicant of record for K250911.

How long did the K250911 review take?

FDA received the submission on Mar 26, 2025 and issued its decision on Oct 17, 2025, 205 days later.

← All decisions in October 2025