# K131704: Epidose

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Aug 5, 2013 after 55 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 K935928 (1994). 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)
- K935928: Rit 113 Film Analysis System, Radiological Imaging Technology, Inc. (1994) Summary page 1.

## Indications for use
Model 1214 EPIDose is a radiotherapy beam QA software application intended for two-dimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS). EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.

Source page: https://510kreport.com/device/K131704
Methodology: https://510kreport.com/methodology