# K082653: Centering Intraluminal Applicator

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 10, 2008 after 28 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: 2 generations back to K912555 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.

## Most influential descendants
- K162499: Best Instruminal Applicator (2018), 0 descendants of its own

## Indications for use
The indications for use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

Source page: https://510kreport.com/device/K082653
Methodology: https://510kreport.com/methodology