# K081281: Ocentra Masterplan 3.1 (Ocentra Brachy)

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corporation
- Decided: May 20, 2008 after 14 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862643 (1987). 10 ancestors in all.
54 later devices descend from it; 5 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031349: OTP 1.2, Nucletron Corp. (2003) Summary page 1.
- K983343: Plato Brachytheraphy, Model V. 14.0, Nucletron Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K120387: Raystation (2012), 22 descendants of its own

## Recalls of this device
- May 21, 2015 · Class II · Z-1712-2015: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
- Aug 21, 2012 · Class II · Z-0118-2013: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and r

## Indications for use
The Oncentra MasterPlan system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

Source page: https://510kreport.com/device/K081281
Methodology: https://510kreport.com/methodology