# K032067: Mammosite Radiation Therapy System (RTS) Tray, Mammosite  HDR Afterloader Accessories Tray

- Pathway: 510(k) (Traditional)
- Applicant: Proxima Therapeutics, Inc.
- Decided: Feb 10, 2004 after 222 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: 5 generations back to K864210 (1986). 9 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 19 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)
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2003) Summary page 1.
- K853912: Microselection Interstitial Remote Afterload Sys, Nucletron-Oldelft Corp. (1986) Summary page 1.
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE, Nucletron Corp. (1999) Summary page 1.

## Most influential descendants
- K050843: Axxent Electronic Brachytherapy System (2005), 8 descendants of its own
- K072683: Axxent Electronic Brachytherapy System (2008), 5 descendants of its own
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110 (2013), 4 descendants of its own
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (2016), 1 descendant of its own
- K132092: Esteya (2013), 1 descendant of its own

## Indications for use
The MamrnoSite 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/K032067
Methodology: https://510kreport.com/methodology