# K070678: Ddrcompact, Ddrcompact Plus and Ddrcompact Chest

- Pathway: 510(k) (Traditional)
- Applicant: Swissray International, Inc.
- Decided: May 2, 2007 after 51 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II(stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

Source page: https://510kreport.com/device/K070678
Methodology: https://510kreport.com/methodology