# K111299: Axxent Radiation Shield - Rigid

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, an Icad Company
- Decided: Jul 20, 2011 after 72 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: 3 generations back to K864210 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992577: Photon Radiosurgery System (PRS), Photoelectron Corporation (1999) Summary page 1.

## Indications for use
Use of the Axxent Radiation Shield - Rigid is indicated in cases in which protection of tissue and/or organs from x-radiation is desired. The Axxent Radiation Shield - Rigid can be used externally and internally, such as during intraoperative radiation therapy (JORT) when the treatment site is exposed surgically.

Source page: https://510kreport.com/device/K111299
Methodology: https://510kreport.com/methodology