# K151426: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

- Pathway: 510(k) (Traditional)
- Applicant: Scandidos AB
- Decided: Jan 29, 2016 after 246 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: 4 generations back to K914698 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062817: PTW David Imrt QC Verification System, Ptw-New York Corp. (2006) Summary page 4.
- K072374: Compass, Scanditronix Wellhofer GmbH (2007) Summary page 4.

## Most influential descendants
- K180697: Pseudo-Patient (2018), 0 descendants of its own

## Indications for use
The intended use of the device is - quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking) - quality assurance of the radiation delivery system.

Source page: https://510kreport.com/device/K151426
Methodology: https://510kreport.com/methodology