# K161540: Advanced Breast Template System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 20, 2016 after 139 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 K952913 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023220: Varisource Breast Template System, Varian Medical Systems (2002) Summary page 5.

## Indications for use
The Advanced Breast Template System is intended for use for cancer treatment of the breast or chest wall using high dose rate HDR Brachytherapy.

Source page: https://510kreport.com/device/K161540
Methodology: https://510kreport.com/methodology