# K072445: Integrated Brachytherapy Unit - Digital

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corp.
- Decided: Sep 14, 2007 after 15 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973848 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973848: Ibu, Integrated Brachy Therapy Unit, Nucletron Corp. (1998) Summary page 1.

## Indications for use
The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.

Source page: https://510kreport.com/device/K072445
Methodology: https://510kreport.com/methodology