# K963451: Anti-Tumor Expert System (Ates) for Radiation Therapy Treatment Planning

- Pathway: 510(k) (Traditional)
- Applicant: Topslane
- Decided: Aug 5, 1997 after 336 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 K940237 (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)
- K940237: Theraplan V05B/ TP-11 V09B, Theratronics, Inc. (1994) Summary page 1.

## Indications for use
The ARTP (Anti Tumor Radiation Treatment Planning System) is a radiation therapy treatment planning system for radiation dose planning and simulation of patients undergoing external beam treatment in the oncology clinic. ARTP is used to plan and simulate radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60 and electron energies from 1 to 25 MeV.

Source page: https://510kreport.com/device/K963451
Methodology: https://510kreport.com/methodology