# K063839: Positioner

- Pathway: 510(k) (Traditional)
- Applicant: C-Rad Positioning AB
- Decided: Feb 8, 2007 after 44 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 K981153 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052682: Alignrt, Vision RT Limited (2006) Summary page 1.

## Indications for use
The Positioner system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as dose as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

Source page: https://510kreport.com/device/K063839
Methodology: https://510kreport.com/methodology