# K050718: Ddrcombi Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Swissray International, Inc.
- Decided: May 26, 2005 after 66 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- 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.
- (no number) AddOn Multi System: named in the summary without a submission number

## Recalls of this device
- Nov 14, 2018 · Class II · Z-0697-2019: A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take

## Indications for use
The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class Il (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms. The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position. With the fix height adjustable patient table and the new flexible detector positioning, the patient must be no more repositioned for the most X-ray applications. The ddRCombi Trauma allows the operator a full control of the Patient data, positioning, X-ray parameter (automatic by organ selection or manual setlings), exposure control and image quality. The operator can use the following image control functions without losing the original exposure: - Brightness, contrast, shape, rotate, zoom, inverse, cut off etc. - Storage function (PACS, HL 7) included all X-ray parameter and patient information The ddRCambi Trauma allows the operator to print images (DICOM format) in background on a laser printer (the most printer suppliers are avaitable) or CO-ROM. The major system components are: fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors.

Source page: https://510kreport.com/device/K050718
Methodology: https://510kreport.com/methodology