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EPIGray

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K112723

by Dosisoft SA

Identifiers

510(k) Number
K112723 FDA 510(k)
FDA Product Code
MUJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EPIGray is a System, Planning, Radiation Therapy Treatment device designed for in vivo dosimetry in radiation therapy. It leverages an Electronic Portal Imaging Device (EPID) to monitor and verify delivered radiation doses in real time, ensuring accuracy during treatment workflows.

EPIGray is used in radiation oncology settings to detect deviations in dose delivery during patient treatment, identifying potential errors in workflow or setup. Supplied as a software module, it operates in conjunction with existing radiation therapy systems and does not require additional sterility measures. Authorized under FDA 510(k) clearance and MDD compliance, it is classified as a Class II medical device under regulation number 892.5050.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EPIgray® - DOSIsoft, home - DOSIsoft, Radiation therapy software module - EPIgray® - DOSIsoft - radiation ..., Effectiveness of EPID-based in-vivo dosimetry with EPIgray

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dosisoft SA

Sources (2)

  • FDA 510(k) K112723 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026