# K953946: Microselectron-HDR Version 2

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron-Oldelft Corp.
- Decided: Aug 13, 1996 after 358 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: 1 generation back to K864210 (1986). 2 ancestors in all.
106 later devices descend from it; 28 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864210: Microselectron-HDR (High Dose Rate), Nucletron-Oldelft Corp. (1986) Summary page 2.
- K925956: Microselectron - HDR for Mobile Environment, Nucletron-Oldelft Corp. (1993) Summary page 2.

## Most influential descendants
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE (1999), 42 descendants of its own
- K983337: Rotterdam Nasophayrnx Mould Set, Part #089.068 (1999), 36 descendants of its own
- 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
- K020015: Implant Guidance System Applicator Set (2002), 20 descendants of its own

Source page: https://510kreport.com/device/K953946
Methodology: https://510kreport.com/methodology