EPIGray Radiation Therapy Dosimetry System

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK112723	Date8 Feb 2012Cleared	StatusActive
European Union	CE/MDD EUDAMED	Number—	Date—	StatusActive

Official records

EUDAMED public site
FDA 510(k) database 510(k) number K112723

Across registries

2 registries list this device

FDA 510(k) K112723 decided 8 Feb 2012 Active
EUDAMED Active

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number: K112723
FDA product code: MUJ

Device class: Class II
Regulation: 21 CFR Part 892.5050
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Dusimetry Check K101503 4 Aug 2010 FDA record · FDA summary

Cited by

iViewDose R1.0 K153011 11 Dec 2015 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K112723

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K112723
		UDI-DI	Size and differences
EPIgray 2.0.10 DOSISOFT	EP1001 / 2.0.10	B501EPIGRAY020010	—	On the market
EPIgray 2.0.6 DOSISOFT	2.0.6 / 2.0.6	B501EPIGRAY020006	—	On the market
EPIgray 2.0.7 DOSISOFT	2.0.7 / 2.0.7	B501EPIGRAY020007	—	On the market

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Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

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