# K122951: Xoft Axxent Electronic Brachytherapy System Model 110

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Jan 17, 2013 after 114 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: 8 generations back to K864210 (1986). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072683: Axxent Electronic Brachytherapy System, Xoft, Inc. (2008) Summary page 2.
- K061582: Varisource 200 HDR Afterloader, Varian Medical Systems, Inc. (2006) Summary page 2.

## Most influential descendants
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200 (2016), 1 descendant of its own
- K132092: Esteya (2013), 1 descendant of its own
- K213942: Esteya (2022), 0 descendants of its own
- K182641: Sensus IORT System (2019), 0 descendants of its own

## Indications for use
The Axxent® Electronic Brachytherapy System is a high dose rate brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.

Source page: https://510kreport.com/device/K122951
Methodology: https://510kreport.com/methodology