# K031349: OTP 1.2

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corp.
- Decided: Aug 7, 2003 after 100 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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 K862643 (1987). 7 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970236: Theraplan Plus Version 1.2, Theratronics, Inc. (1997) Summary page 2.

## Most influential descendants
- 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
- K102216: Xio RTP System (2010), 27 descendants of its own

## Indications for use
OTP is radiation treatment planning software designed to analyze and plan rahation treatments in three dimensions for the purpose of treating patients with cancer.

Source page: https://510kreport.com/device/K031349
Methodology: https://510kreport.com/methodology