# K020015: Implant Guidance System Applicator Set

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corp.
- Decided: Mar 13, 2002 after 69 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.
20 later devices descend from it; 1 cites it directly.
0 of 24 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
- K032372: Nucletron Comfort Catheter System, Model 189.007 (2003), 19 descendants of its own
- K061241: Biolucent Applicator, Model Rta-XX (2006), 17 descendants of its own
- K070659: Biolucent Applicator Kit (2007), 13 descendants of its own
- K080565: Modification to: Savi Applicator Kit (2008), 12 descendants of its own
- K081677: Savi Applicator Kit (2008), 11 descendants of its own

## Indications for use
Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. 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/K020015
Methodology: https://510kreport.com/methodology