# K113102: Oncentra Manual Low Dose Rate Treatment Planning

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron
- Decided: Dec 12, 2011 after 54 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 K911612 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion, The software also provides the treatment time and dose distribution for the specific loading. From this information the patient can be treated with radioactive sources.

Source page: https://510kreport.com/device/K113102
Methodology: https://510kreport.com/methodology