# K213137: INTDose

- Pathway: 510(k) (Traditional)
- Applicant: Carina Medical, LLC
- Decided: May 13, 2022 after 228 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: 7 generations back to K914698 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180595: SciMoCa, Radialogica, LLC (2018) Summary page 4.

## Indications for use
INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.

Source page: https://510kreport.com/device/K213137
Methodology: https://510kreport.com/methodology