# K060299: Art Brachytherapy Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Radiation Therapy, LLC
- Decided: Jun 6, 2006 after 120 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 K961601 (1996). 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)
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 1.
- K983338: Freiburg Flap Applicator Set, Part Number 089.095, Nucletron Corp. (1999) Summary page 1.
- (no number) Varian Medical Systems - Catheter Flap: named in the summary without a submission number

## Most influential descendants
- K062135: Art Shielded Breast Applicator (2006), 0 descendants of its own

## Indications for use
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source on the periphery of the breast to deliver radiation dose to the underlying tissue in areas of intact skin.

Source page: https://510kreport.com/device/K060299
Methodology: https://510kreport.com/methodology