# K991319: Raycast Immobilization Systems Hardware and Thermoplastic Materials

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries
- Decided: Sep 21, 1999 after 155 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081218: Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast (2008), 0 descendants of its own
- K050888: Integra Immobilization System (2005), 0 descendants of its own

## Indications for use
The RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials are used to retain and reproduce a patient’s position during radiation therapy.

Source page: https://510kreport.com/device/K991319
Methodology: https://510kreport.com/methodology