# K980296: Oldelft Digidelca

- Pathway: 510(k) (Traditional)
- Applicant: Oldelft Corp. of America
- Decided: Apr 17, 1998 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
Longest line of descent: 1 generation back to K892659 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892659: Electrodelca, Oldelft Corp. of America (1989) Summary page 2.
- K950343: Hyperpacs Pacs and Telerafiology System, Rogan Imaging Corp. (1995) Summary page 2.
- K973219: Amber DU, Oldelft Corp. of America (1997) Summary page 2.

## Most influential descendants
- K012165: Oldelft Thorascan Model Number 180T (2001), 0 descendants of its own

## Indications for use
Digidelca provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on CCD technology. The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operators workstation only seconds after the x-ray exposure. After acceptance by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.g. clinical review station or to a film printer. Note: PACS, networks, clinical review stations and (laser-) film printers are not considered part of the Digidelca system for which this application is filed, only external interfacs to this type of equipment are defined.

Source page: https://510kreport.com/device/K980296
Methodology: https://510kreport.com/methodology