# K110828: Ddrelement

- Pathway: 510(k) (Traditional)
- Applicant: Swissray Medical AG
- Decided: Aug 23, 2011 after 152 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123005: Ddrversa Motion (2012), 4 descendants of its own
- K141381: Duradiagnost (2014), 3 descendants of its own
- K163410: DigitalDiagnost C50 (2017), 1 descendant of its own
- K201725: DigitalDiagnost C50 (2020), 0 descendants of its own
- K201640: DuraDiagnost (2020), 0 descendants of its own

## Indications for use
The ddRElement is a Digital Radiography system developed to be used for Medical

Source page: https://510kreport.com/device/K110828
Methodology: https://510kreport.com/methodology