# K161946: DoseCHECK

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Sep 16, 2016 after 63 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 K914698 (1992). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140660: MOBIUS3D, Mobius Medical Systems, LP (2014) Summary page 5.

## Most influential descendants
- K180595: SciMoCa (2018), 3 descendants of its own
- K223234: Delta4 Insight (2024), 0 descendants of its own
- K231273: ArcherQA (V1.0) (2024), 0 descendants of its own
- K213137: INTDose (2022), 0 descendants of its own

## Indications for use
Sun Nuclear’s DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.

Source page: https://510kreport.com/device/K161946
Methodology: https://510kreport.com/methodology