# K112723: Epigray

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft SA
- Decided: Feb 8, 2012 after 142 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 2 generations back to K010225 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101503: Dusimetry Check, Math Resolutions, LLC (2010) Summary page 1.

## Most influential descendants
- K153011: iViewDose R1.0 (2015), 0 descendants of its own

## Indications for use
EPigray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning system. This product in not used to give a prescription of the radiation therapy.

Source page: https://510kreport.com/device/K112723
Methodology: https://510kreport.com/methodology