# K091378: Mammosite II Radiation Therapy System

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Jul 2, 2009 after 52 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: 8 generations back to K864210 (1986). 26 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041929: Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2004) Summary page 1.
- K081079: Contura MLB Source Applicator for Brachytherapy, Senorx, Inc. (2008) Summary page 1.
- K081677: Savi Applicator Kit, Cianna Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own
- K171885: Radiance V4 (2017), 3 descendants of its own
- K162568: Intrabeam 600 (2016), 1 descendant of its own

## Indications for use
The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Source page: https://510kreport.com/device/K091378
Methodology: https://510kreport.com/methodology