# K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray

- Pathway: 510(k) (Traditional)
- Applicant: Proxima Therapeutics, Inc.
- Decided: May 21, 2003 after 89 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: 4 generations back to K864210 (1986). 8 ancestors in all.
33 later devices descend from it; 6 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2002)

## Most influential descendants
- K041929: Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (2004), 17 descendants of its own
- K071229: Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy (2007), 14 descendants of its own
- K081079: Contura MLB Source Applicator for Brachytherapy (2008), 11 descendants of its own
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own
- K032067: Mammosite Radiation Therapy System (RTS) Tray, Mammosite  HDR Afterloader Accessories Tray (2004), 9 descendants of its own

## Indications for use
The MammoSite 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/K030558
Methodology: https://510kreport.com/methodology