# K180595: SciMoCa

- Pathway: 510(k) (Traditional)
- Applicant: Radialogica, LLC
- Decided: Apr 4, 2018 after 29 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 K914698 (1992). 15 ancestors in all.
3 later devices descend from it; 3 cite 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.
- K161946: DoseCHECK, Sun Nuclear Corporation (2016) Summary page 5.

## Most influential descendants
- 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
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses. SciMoCa 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/K180595
Methodology: https://510kreport.com/methodology