# K973710: Digital Add on Multi System

- Pathway: 510(k) (Traditional)
- Applicant: Swissray International, Inc.
- Decided: Dec 18, 1997 after 80 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
- K073056: Digital Radiography System, Model: QXR-9 (2007), 4 descendants of its own
- K080553: Digital Radiography System, Model QXR-16 (2008), 2 descendants of its own
- K101779: Clearvision DR 2000 Digital Radiography X-Ray System (2011), 0 descendants of its own
- K100703: Stationary X-Ray System (Detector) Model: Altas (2010), 0 descendants of its own
- K082261: Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems (2008), 0 descendants of its own

## Indications for use
The Swissray Telleray AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in muitipurpose or dedicated applications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position. The AddOn multi system allows the operator to view and enhance the images. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. The Add-on multi system enables the operator to hardcopy images with a laser printer. The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.

Source page: https://510kreport.com/device/K973710
Methodology: https://510kreport.com/methodology