# K140825: Delworks DR System

- Pathway: 510(k) (Traditional)
- Applicant: Del Medical, Inc.
- Decided: Jul 17, 2014 after 107 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 30 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T, Sedecal., Sa. (2013) Summary page 1.

## Most influential descendants
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own
- K223060: DigiX FDX (2022), 4 descendants of its own
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own

## Indications for use
The Del Works DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-Film systems may be used, excluding fluoroscopy, angiography and mammography. Dcl Works DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis. and extremities.

Source page: https://510kreport.com/device/K140825
Methodology: https://510kreport.com/methodology