# K021286: Microselectron HDR- Genie Afterloading System, Model 105.989 for 115VOLT Devices and 105.988 for 230VOLT Devices

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corp.
- Decided: May 23, 2002 after 30 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)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.

## Indications for use
The Nuecletron microSelectron HDR - GENTE Afterloading System has the same intended use ss the legally marketed predicate device cited. This device is intended to enable an operator to apply, by remote control, a radionuclide source into the body or te the surface of the body for radiation therapy.

Source page: https://510kreport.com/device/K021286
Methodology: https://510kreport.com/methodology