# K132816: Oncentra Brachy

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Jun 13, 2014 after 277 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: 5 generations back to K862643 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121448: Oncentra, Oncentra External Beam, Oncentra Brachy, Elekta Inc. D/B/A Nucletron Corporation (2012) Summary page 2.

## Recalls of this device
- Dec 5, 2022 · Class II · Z-0719-2023: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
- Oct 13, 2021 · Class II · Z-0182-2022: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
- Aug 10, 2017 · Class II · Z-0050-2018: Incorrect source step size may occur in the software plans

## Indications for use
Oncentra is a radiation therapy 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/K132816
Methodology: https://510kreport.com/methodology