# K080929: Oncentra Gyn

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corporation
- Decided: Apr 16, 2008 after 15 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: 4 generations back to K911612 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031158: Swift 2.0, Model 132.001, Nucletron Corp. (2003) Summary page 1.

## Indications for use
Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

Source page: https://510kreport.com/device/K080929
Methodology: https://510kreport.com/methodology