Oldelft gets U.S. clearance for digital radiography systems

Company offers two versions of CCD-based scanners

The U.S. digital x-ray market now has another participant. Dutch digital x-ray developer Oldelft has received Food and Drug Administration 510(k) clearance for its Digidelca line of CCD-based digital chest radiography systems.

The Digidelca offerings will compete in the dedicated chest radiography realm against traditional CR manufacturers such as Fuji and Philips, and also against Imix, another CCD-based digital radiography system sold in the U.S. by Advanced Instrument Development (SCAN 4/1/98). Demonstrated as works-in-progress at last year's Radiological Society of North America meeting (SCAN Special Report 12/97), Digidelca-C is targeted for dedicated chest imaging applications, while Digidelca-M is designed for tuberculosis screening and imaging of occupational lung disease.

A key benefit of the Digidelca line is its use of proven technologies such as CCD and slot scanning, a technique commonly employed in mammography scanners, said Hans Bossink, CEO of Oldelft's Columbia, MD-based U.S. division, Oldelft Corporation of America. Slot scanning uses a small fan-shaped image beam, which results in decreased image scatter, Bossink said.

In addition, Oldelft points to its Advanced Multiple Beam Equalization Radiology (AMBER) option, which allows Digidelca-C to adjust the amount of x-rays for each thorax imaging location being scanned. Since the optimal amount of radiation required to penetrate each specific imaging region is employed, the technique produces excellent image quality, Bossink said.

Oldelft also believes the pricing of the systems will strike a chord in the market. 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.

Both systems feature a 2K x 2K x 12-bit camera unit, with a detector field size of 40 x 40 cm. Focal spot size is 1.3 mm. Digidelca-C features 0.9-second exposure scan time, while Digidelca-M takes 1.2 seconds. Since Digidelca-M is designed as a screening system, it employs a JPEG compression scheme to compress an image from 10 MB to 1 MB, according to the company. Digidelca-C does not employ compression, since all image data are required in a clinical system, Bossink said.

Digidelca-M is not typically connected to a hospital PACS network, but Digidelca-C can be interfaced to networks via an optional HIS/RIS interface provided by Rogan Medical Systems. PACS connectivity is enabled via a DICOM 3.0 data export capability, according to the firm. Oldelft will sell the Digidelca line in the U.S. via a dealer network.

International shipments of Digidelca units have been under way since January, and the company has fewer than 10 systems installed in countries such as Brazil, Bulgaria, Japan, and the Netherlands. The company expects its first U.S. shipment will take place in September.