# K201119: ChartCheck

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Jun 26, 2020 after 60 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 K952313 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173838: ARIA Radiation Therapy Management, Varian Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K252988: ChartCheck (RADCH V1.6) (2026), 0 descendants of its own

## Indications for use
The ChartCheck device is intended for the quality assessment of radiotherapy treatment plans and on treatment chart review.

Source page: https://510kreport.com/device/K201119
Methodology: https://510kreport.com/methodology