# K062135: Art Shielded Breast Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Radiation Therapy, LLC
- Decided: Nov 7, 2006 after 104 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: 6 generations back to K864210 (1986). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060299: Art Brachytherapy Applicator, Advanced Radiation Therapy, LLC (2006) Summary page 1.
- K052351: HDR Iort Shielded Applicator, Mick Radio-Nuclear Instruments, Inc. (2005) Summary page 1.
- K033371: Varian Intracavitary Brachytherapy Applicators, Varian Medical Systems (2003) Summary page 1.

## Indications for use
The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.

Source page: https://510kreport.com/device/K062135
Methodology: https://510kreport.com/methodology