# K864210: Microselectron-HDR (High Dose Rate)

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron-Oldelft Corp.
- Decided: Nov 26, 1986 after 29 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
No predicates in its family tree.
112 later devices descend from it; 4 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K953946: Microselectron-HDR Version 2 (1996), 106 descendants of its own
- 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

Source page: https://510kreport.com/device/K864210
Methodology: https://510kreport.com/methodology