# K250911: MOSkin Radiation Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Electrogenics Labs, Ltd.
- Decided: Oct 17, 2025 after 205 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092285 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092285: Portable Dosimeter Dose Verification System, Model TD-RD-90, Best Medical Canada, Ltd. (2009) Summary page 5.

## Indications for use
The MOSkin radiation measurement system intended use is a dosimeter to measure radiation dose delivered by a radiation source to the location of an Radiation Dosimeter (RD) sensor on the patient in a clinical use environment. The system is intended for the verification of the output of radiation producing devices. The output of the system is not used to directly adjust the radiation dose to the patient.

Source page: https://510kreport.com/device/K250911
Methodology: https://510kreport.com/methodology