# K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Feb 25, 2016 after 73 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). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 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 5.

## Most influential descendants
- K182641: Sensus IORT System (2019), 0 descendants of its own

## Indications for use
The Axxent® Electronic Brachytherapy System Model 110 XP 1200 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. Only Xoft Axxent Surface Applicators can be used with the Axxent Electronic Brachytherapy System Model 110 XP 1200.

Source page: https://510kreport.com/device/K153570
Methodology: https://510kreport.com/methodology