# K162468: ClearCheck

- Pathway: 510(k) (Traditional)
- Applicant: Radformation
- Decided: Dec 1, 2016 after 90 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: 12 generations back to K954874 (1996). 48 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142142: Quality Reports, Sun Nuclear Corporation (2014) Summary page 6.

## Most influential descendants
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own
- K231185: MapRT (2023), 1 descendant of its own
- K253962: ClearCheck (RADCC V2.7) (2026), 0 descendants of its own
- K243301: MapRT (2025), 0 descendants of its own

## Indications for use
ClearCheck is intended for quality assessment of radiotherapy treatment plans.

Source page: https://510kreport.com/device/K162468
Methodology: https://510kreport.com/methodology