MOSkin Radiation Measurement System

FDA 510(k) K250911 · Electrogenics Labs, Ltd.

Substantially Equivalent

510(k) numberK250911

Submission

Device name
MOSkin Radiation Measurement System
Applicant
Electrogenics Labs, Ltd.
North Sydney, AU
Received
March 26, 2025
Decision date
October 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was MOSkin Radiation Measurement System cleared by the FDA?

MOSkin Radiation Measurement System (K250911) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 205 days after the submission was received.

What is the product code of K250911?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.