# K983115: Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Apr 2, 1999 after 210 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.
No later device cites it as a predicate yet.
0 of 4 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.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 2.

## Indications for use
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.

Source page: https://510kreport.com/device/K983115
Methodology: https://510kreport.com/methodology