# K970236: Theraplan Plus Version 1.2

- Pathway: 510(k) (Traditional)
- Applicant: Theratronics, Inc.
- Decided: Jul 9, 1997 after 169 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 K862643 (1987). 6 ancestors in all.
65 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954679: Theraplan Plus, Theratronics, Inc. (1996) Summary page 1.
- K940237: Theraplan V05B/ TP-11 V09B, Theratronics, Inc. (1994) Summary page 1.
- K921991: Plato Radiation Therapy Planning System, Nucletron-Oldelft Corp. (1992) Summary page 1.
- K862643: Radiation Oncology Computer Sys Treatment Planning, Pacific Physics, Inc. (1987) Summary page 1.
- K894722: Renner-Plan, W.D. Renner Consulting Co. (1990) Summary page 1.
- K926008: Pinnacle 3, Adac Laboratories (1994) Summary page 1.

## Most influential descendants
- K031349: OTP 1.2 (2003), 59 descendants of its own
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy) (2008), 54 descendants of its own
- K092132: Xio RTP System (2009), 34 descendants of its own
- K083264: Rayautoplan 1.0 (2009), 31 descendants of its own
- K100552: Raystation Version 1.0 (2010), 30 descendants of its own

## Indications for use
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.

Source page: https://510kreport.com/device/K970236
Methodology: https://510kreport.com/methodology