# K132092: Esteya

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Sep 26, 2013 after 83 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864210 (1986). 22 ancestors in all.
1 later device descends 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)
- K122951: Xoft Axxent Electronic Brachytherapy System Model 110, Icad, Inc. (2013) Summary page 1.
- K073107: Valencia Skin Applicator Set, Model: 189.701, Nucletron Corporation (2007) Summary page 1.
- K063456: SRT100 Superficial Radiation Therapy System, Topex, Inc. (2007) Summary page 1.

## Most influential descendants
- K213942: Esteya (2022), 0 descendants of its own

## Indications for use
The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for surface brachytherapy procedures. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma. Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Malingna Melanoma, Keloids and Cutaneous Lymphoma (B and T cell).

Source page: https://510kreport.com/device/K132092
Methodology: https://510kreport.com/methodology