# K162862: Raycast High Precision Lung Board Solution

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries NV
- Decided: Nov 9, 2016 after 28 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: 2 generations back to K895697 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040773: Pelvis Bellyboard Plus Patient Positioning System, Bionix Development Corp. (2004) Summary page 4.

## Indications for use
The Raycast High Precision Lung Board Solution is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K162862
Methodology: https://510kreport.com/methodology