# K252988: ChartCheck (RADCH V1.6)

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Jan 5, 2026 after 109 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: 6 generations back to K952313 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201119: ChartCheck, Radformation, Inc. (2020) Summary page 6.

## Indications for use
ChartCheck is intended to assist with the quality assessment of radiotherapy treatment plans and on treatment review.

Source page: https://510kreport.com/device/K252988
Methodology: https://510kreport.com/methodology