# K050888: Integra Immobilization System

- Pathway: 510(k) (Traditional)
- Applicant: Diacor, Inc.
- Decided: May 23, 2005 after 46 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991319 (1999). 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)
- K991319: Raycast Immobilization Systems Hardware and Thermoplastic Materials, Orfit Industries (1999) Summary page 1.

## Indications for use
To enable head and neck immobilization for patient placement during radiation therapy planning and treatment.

Source page: https://510kreport.com/device/K050888
Methodology: https://510kreport.com/methodology