# K973936: Focus RTP System

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Jun 1, 1998 after 229 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: 2 generations back to K894706 (1989). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951581: PINNACLE3 Apex, Adac Laboratories (1996) Summary page 1.
- K940001: Plato-SRS (Stereo Radiosurgery Treatment Planning Sys), Nucletron Corp. (1995) Summary page 1.
- K953482: Xknife-3, Radionics Software Applications, Inc. (1995) Summary page 1.

## Most influential descendants
- K090182: Module Integrated Radiotherapy System (Mirs) (2009), 0 descendants of its own

## Indications for use
To calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient diagnosed as having single or multiple brain lesions based on user-defined radiation treatment plan parameters.

Source page: https://510kreport.com/device/K973936
Methodology: https://510kreport.com/methodology