# K081179: Mammosite Cavity Evaluation Device

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 9, 2008 after 14 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.
2 later devices descend from it; 2 cite it directly.
0 of 12 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) Summary page 2.
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2003) Summary page 1.

## Most influential descendants
- K092323: Contura Cavity Maintenance Catheter (2009), 1 descendant of its own
- K101411: Savi Preparation Device (2010), 0 descendants of its own

## Indications for use
The MammoSite Cavity Evaluation Device (CED) may be used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite Radiation Therapy System (RTS) applicator. It may be used during surgery to assess skin spacing and conformance. The CED may also be left in the lumpectomy cavity as a placeholder until it is exchanged for the MammoSite RTS applicator.

Source page: https://510kreport.com/device/K081179
Methodology: https://510kreport.com/methodology