# K223465: RadianceTx Radionuclide Brachytherapy Source

- Pathway: 510(k) (Traditional)
- Applicant: Radiance Therapeutics, Inc.
- Decided: Jan 11, 2023 after 55 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of tumors and benign growths. The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.

Source page: https://510kreport.com/device/K223465
Methodology: https://510kreport.com/methodology