# K090417: Axxent Flexishield Mini

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, Inc.
- Decided: Jun 23, 2009 after 125 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010172 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010172: Lead Blocks, Arplay Medical S.A. (2001) Summary page 2.

## Recalls of this device
- Feb 3, 2011 · Not classified · Z-1865-2011: Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiati

## Indications for use
To shape the beam from a low energy radiation therapy source up to 50 kVp.

Source page: https://510kreport.com/device/K090417
Methodology: https://510kreport.com/methodology