# K151180: ScandiDos Delta4 Phantom+

- Pathway: 510(k) (Traditional)
- Applicant: Scandidos AB
- Decided: Aug 19, 2015 after 107 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: 3 generations back to K935928 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052920: DELTA4, Scandidos AB (2006) Summary page 4.

## Indications for use
The intended use of the device is: • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). • quality assurance of the radiation delivery system.

Source page: https://510kreport.com/device/K151180
Methodology: https://510kreport.com/methodology