# K052920: DELTA4

- Pathway: 510(k) (Traditional)
- Applicant: Scandidos AB
- Decided: Jan 12, 2006 after 87 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: 2 generations back to K935928 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031634: Omnipro I'mrt, Wellhofer Dosimetrie (2003) Summary page 1.
- (no number) MapCheck: named in the summary without a submission number
- (no number) CIRS Model 008 Dynamic Thorax Phantom: named in the summary without a submission number

## Most influential descendants
- K151180: ScandiDos Delta4 Phantom+ (2015), 0 descendants of its own

## Indications for use
The intended use of Delta4 is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).

Source page: https://510kreport.com/device/K052920
Methodology: https://510kreport.com/methodology