# K052943: Ddrformula and Ddrformula Plus

- Pathway: 510(k) (Traditional)
- Applicant: Swissray Medical AG
- Decided: Dec 15, 2005 after 56 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (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 18, 2016 · Class II · Z-3191-2018: Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
- Aug 9, 2016 · Class II · Z-3248-2018: Possible injury due to movement of the arm, calibration loss and communication loss.

## Indications for use
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a flat panel (a-Si) X-ray detector (FP5000) and is designed for applying general radiography 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/K052943
Methodology: https://510kreport.com/methodology