Oldelft joins digital x-ray fray with FDA clearance of Digidelca

Oldelft joins digital x-ray fray with FDA clearance of Digidelca

Company offers two versions of CCD-based system

Add Dutch firm Oldelft to the list of combatants participating in the U.S. digital chest radiography market. The digital x-ray developer has received Food and Drug Administration 510(k) clearance for its Digidelca line of CCD-based digital chest radiography systems.

For dedicated chest imaging, Oldelft offers Digidelca-C. Another product, Digidelca-M, is targeted for tuberculosis screening and imaging of occupational lung disease. Both systems were demonstrated as works-in-progress at the 1997 Radiological Society of North America meeting.

Digidelca-C and Digidelca-M feature a 2K x 2K x 12-bit camera unit with a detector field size of 40 x 40 cm and a focal spot size of 1.3 mm. Digidelca-C yields 0.9-second exposure scan time, while Digidelca-M takes 1.2 seconds.

In addition to CCD-based technology, the Digidelca scanners employ slot scanning, a technique commonly used in mammography systems, said Hans Bossink, CEO of the company's Columbia, MD-based U.S. division. The slot scanning technique relies on a small fan-shaped beam, which leads to decreased image scatter, he said.

A key benefit of the Digidelca-C system is the company's Advanced Multiple Beam Equalization Radiology (AMBER) option, which enables the scanner to adjust the amount of x-rays for each thorax imaging location being scanned. The technique yields excellent image quality, as the optimal amount of radiation required to penetrate each specific imaging region is employed, Bossink said.

For connection to hospital networks, Digidelca-C can be equipped with an optional HIS/RIS interface provided by PACS firm Rogan Medical Systems. PACS connectivity is enabled via a DICOM 3.0 data export capability, according to the company. Digidelca-M is not typically hooked up to hospital networks.

Oldelft initiated international sales of the units in January, and has installed fewer than 10 systems in countries such as Brazil, Bulgaria, Japan, and the Netherlands. U.S. sales will be conducted via a dealer network, and the company expects its first shipment to occur in September. A complete Digidelca-C or Digidelca-M system, including the operator workstation, generator, and x-ray components, will cost $200,000 to $300,000, depending on configuration.

In the U.S. digital chest radiography market, the Digidelca scanners will compete against traditional computed radiography products from vendors such as Fuji and Philips. In addition, the Digidelca line will go head-to-head with Imix, another CCD-based digital chest radiography system sold in the U.S. by Advanced Instrument Development (PNN 5/98). Flat-panel-based systems from Sterling Diagnostic Imaging and other companies also loom in this increasingly competitive imaging sector.

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