# K040709: Protos Software

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Apr 28, 2004 after 41 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
External Beam Radiation Therapy is typically delivered to patients from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants). AKTINA Medical Physics Corporation has designed and manufactured software to aid in the verification of the delivery prior to radiotherapy treatment. The software analyzes and compares the predicted data from a treatment planning computer to measured data from delivered dose measurements.

Source page: https://510kreport.com/device/K040709
Methodology: https://510kreport.com/methodology