# K223234: Delta4 Insight

- Pathway: 510(k) (Traditional)
- Applicant: Scandidos AB
- Decided: Jan 16, 2024 after 454 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
Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment plans by an independent dose calculation. Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.

Source page: https://510kreport.com/device/K223234
Methodology: https://510kreport.com/methodology