# K023220: Varisource Breast Template System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Oct 25, 2002 after 28 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952913 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952913: Applicators for Varian Varisource Remote High Soes Rate Afterloader, Varian Assoc., Inc. (1995)

## Most influential descendants
- K161540: Advanced Breast Template System (2016), 0 descendants of its own

## Recalls of this device
- Aug 9, 2013 · Class II · Z-0065-2014: The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.

## Indications for use
The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a futed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are futed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

Source page: https://510kreport.com/device/K023220
Methodology: https://510kreport.com/methodology