# K203722: RayPilot System

- Pathway: 510(k) (Traditional)
- Applicant: Micropos Medical AB
- Decided: Sep 2, 2021 after 255 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: 5 generations back to K911783 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
4 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060906: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2006) Summary page 4.

## Indications for use
The RayPilot@ System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot@ System provides accurate, precise, and continuous localization of a treatment isocenter by using RayPilot@ HypoCath@, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification. The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the duration of the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.

Source page: https://510kreport.com/device/K203722
Methodology: https://510kreport.com/methodology