# K121448: Oncentra, Oncentra External Beam, Oncentra Brachy

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Inc. D/B/A Nucletron Corporation
- Decided: Jul 2, 2012 after 48 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862643 (1987). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy), Nucletron Corporation (2008) Summary page 1.
- K983343: Plato Brachytheraphy, Model V. 14.0, Nucletron Corp. (1999) Summary page 1.

## Most influential descendants
- K132971: Monaco (2013), 7 descendants of its own
- K151233: Monaco (2015), 6 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own
- K190178: Monaco RTP System (2019), 4 descendants of its own
- K202789: Monaco Rtp System (2021), 3 descendants of its own

## Recalls of this device
- Dec 23, 2016 · Class II · Z-0987-2017: Cross profile for Varian 60 degree wedge shows "horns."
- Dec 18, 2015 · Class II · Z-0604-2016: When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and op
- May 21, 2015 · Class II · Z-1712-2015: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

## Indications for use
The Oncentra 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/K121448
Methodology: https://510kreport.com/methodology