# K973848: Ibu, Integrated Brachy Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Jan 22, 1998 after 106 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Simulix-HP: named in the summary without a submission number
- (no number) Integris: named in the summary without a submission number

## Most influential descendants
- K072445: Integrated Brachytherapy Unit - Digital (2007), 0 descendants of its own

## Indications for use
The Integrated Brachytherapy Unit (IBU) is intended to be used for the visualization, localization and confirmation of the volume and size of the Brachy radiation therapy irradiation field(s), using a fluoroscopic and/or radiographic system. Localization and simulation for Brachy radiation therapy can be performed more effectively on the IBU than on a standard radiation treatment simulator. The additional L-arm allows the user to visualize under many angles easier for the operator than with the predicate device. The IBU will not be used for the simulation of external beam radiation treatments.

Source page: https://510kreport.com/device/K973848
Methodology: https://510kreport.com/methodology