# K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray

- Pathway: 510(k) (Traditional)
- Applicant: Proxima Therapeutics, Inc.
- Decided: May 6, 2002 after 340 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: 3 generations back to K864210 (1986). 7 ancestors in all.
34 later devices descend from it; 7 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)
- K003206: Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005, Proxima Therapeutics, Inc. (2001) Summary page 1.
- K853912: Microselection Interstitial Remote Afterload Sys, Nucletron-Oldelft Corp. (1986) Summary page 1.
- K864210: Microselectron-HDR (High Dose Rate), Nucletron-Oldelft Corp. (1986) Summary page 1.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.
- K983337: Rotterdam Nasophayrnx Mould Set, Part #089.068, Nucletron Corp. (1999) 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
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (2003), 33 descendants of its own
- 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

## Indications for use
The MammoSite Radiation Therapy System 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/K011690
Methodology: https://510kreport.com/methodology