# K112420: Oncentra Prostate 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron
- Decided: Nov 18, 2011 after 87 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022741: Spot Pro (220V), Model 131.099, Nucletron Corporation (2002) Summary page 1.
- K031158: Swift 2.0, Model 132.001, Nucletron Corp. (2003) Summary page 1.

## Most influential descendants
- K170841: BiopSee, Mobile US (2017), 0 descendants of its own

## Indications for use
Oncentra Prostate is a software application intended for use with Brachytherapy. procedures, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources The software should only be used by a person trained in brachytherapy techniques (such a person will be referred to as the user).

Source page: https://510kreport.com/device/K112420
Methodology: https://510kreport.com/methodology