# K250696: AccuCheck

- Pathway: 510(k) (Traditional)
- Applicant: Manteia Technologies Co., Ltd.
- Decided: Oct 24, 2025 after 231 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: 15 generations back to K954874 (1996). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223834: AccuCheck, Manteia Technologies Co., Ltd. (2023) Summary page 5.

## Indications for use
AccuCheck is a quality assurance software to the quality assurance of general offline planning, online adaptive planning and various radiotherapy technology such as photon and proton. It is 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 Accelerator 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/K250696
Methodology: https://510kreport.com/methodology