# K983337: Rotterdam Nasophayrnx Mould Set, Part #089.068

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Apr 2, 1999 after 191 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: 2 generations back to K864210 (1986). 3 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.

## Most influential descendants
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (2002), 34 descendants of its own
- 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

## Indications for use
Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Source page: https://510kreport.com/device/K983337
Methodology: https://510kreport.com/methodology