# K200600: Sentinel

- Pathway: 510(k) (Special)
- Applicant: C-Rad Positioning AB
- Decided: Apr 20, 2020 after 42 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: 4 generations back to K981153 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120668: Sentinel, C-Rad Positioning AB (2012) Summary page 4.

## Indications for use
The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: • accurate and reproducible patient positioning. • a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

Source page: https://510kreport.com/device/K200600
Methodology: https://510kreport.com/methodology