FDA approves DBA Systems mammo station

March 15, 2000

Florida-based DBA Systems has received premarket approval from the Food and Drug Administration for its film mammogram review and analysis workstation, ImagClear Mammography Review System. The product line offers several different models. The main

Florida-based DBA Systems has received premarket approval from the Food and Drug Administration for its film mammogram review and analysis workstation, ImagClear Mammography Review System.

The product line offers several different models. The main models—the CV 6000, Tech 5000, and VS 500—are ready and available for clinical use, said Glenn Turner, DBA Systems’ manager of medical research and development.

Company officials said they hope to bridge the gap between film-based and filmless technology with the ImagClear system.

The ImagClear uses hardware, software, and communications technology that allow a radiologist to apply digital imaging techniques to the viewing, manipulation, and communication of film mammograms. Image capture is accomplished through the ImagClear system’s film digitizer, which provides a pixel resolution of 42 microns and a gray-scale range of 16 bits to produce a minimum 4K x 5K image matrix, which is adequate for even the highest quality mammography films.

The image viewing software ImagClear uses was specifically designed to meet the demanding requirements of mammography. Images from the ImagClear Film Digitizer can be organized into studies and sessions and the system creates online reports.