# K970136: Digital Add-on Bucky

- Pathway: 510(k) (Traditional)
- Applicant: Swissray Teleray AG
- Decided: Nov 21, 1997 after 310 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 Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations. The Digital Add-on Bucky 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 Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a CCD camera, monitors and an image processor.

Source page: https://510kreport.com/device/K970136
Methodology: https://510kreport.com/methodology