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Digidelca provides the radiologists or pneumologists the ability to acquire chest xray 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.q. clinical review station or to a film printer.

Digidelca is a product which was developed around hardware and software components which are already market within the United States and therefore substantial equivalence is claimed to Electrodelca for the electrical, mechanical and optical system layout and to AMBER-DU and HyperPACS for the software configuration: - The Oldelft Electrodelca (tm) mass chest x-ray system (K892659) for the camera . housing basic design, the image intensifier tube, the elevator stand basic design and the compatible x-ray tube and high voltage generator selection. The image capturing device in Digidelca is a TDI CCD sensor, instead of radiographic film. - The Rogan HyperPACS (tm) software package (K950343) for the principal software ● tasks for the Operators Workstation: image acquisition and storage, image export, network interfacing. - The Oldelft Amber-DU (K973219) software package (reconfigured) for user interfacing . at the Operators Workstation. The Operators Workstation displays screens to the operator for data input and for data and image display. The Digidelca software is configured as a dedicated shell around the Rogan software which operates in the background to perform essential functions for data acquisition, image storage and image export. The OWS allows for importing patient demographic information and exportation of digital images into which patient demographics have been incorporated (DICOM compatible data structures). The Date Entry System is an additional pc platform which is used to copy patient demographics to a card formation carrier by a thermal printing process. The card is handed out to the examinee who will submit it to the Digidelca(-M) operator prior to making his/het x-rays. Patient demographics are scanned from the card by a two dimensional barcode reader and thereby entered into the Digidelca(-M) operators workstation.

Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital's network server for storage and eventual retrieval if desired.

The Oldelft Amber DU is comprised of the currently marketed Oldelft Amber AU, the Lumisys Lumiscan 75 LASER Film Digitizer which is commercially available, and a digital workstation based on a commercially available workstation from Rogan Imaging Corporation using software written by Rogan to Oldelft's specifications. The workstation displays screens to the operator for data input and for data and image display. The Oldelft Amber DU display is configured as a shell about the Rogan software which operates in the background to perform essential functions and to provide miniPACS features to Amber DU and allow the importation of patient demographic information and to allow the exportation of digital image data into which patient demographics have been incorporated.