# K120668: Sentinel

- Pathway: 510(k) (Traditional)
- Applicant: C-Rad Positioning AB
- Decided: Jul 30, 2012 after 147 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: 3 generations back to K981153 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082582: Sentinel, Model SP-001, C-Rad Positioning AB (2009) Summary page 1.

## Most influential descendants
- K200600: Sentinel (2020), 0 descendants of its own

## 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. * patient motion supervision with an audible and/or visual alarm whenever the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm. * a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (alka 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/K120668
Methodology: https://510kreport.com/methodology