# K223834: AccuCheck

- Pathway: 510(k) (Traditional)
- Applicant: Manteia Technologies Co., Ltd.
- Decided: Jul 20, 2023 after 210 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: 14 generations back to K954874 (1996). 79 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203669: Mobius3D, Varian Medical Systems, Inc. (2021) Summary page 5.

## Most influential descendants
- K250696: AccuCheck (2025), 0 descendants of its own

## Indications for use
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.

Source page: https://510kreport.com/device/K223834
Methodology: https://510kreport.com/methodology