Agfa HealthCare hopes to have FDA approval in 2008 to sell its CR solutions for mammography in the United States. The company’s CR systems were on display at the 93rd scientific assembly and annual meeting of the Radiological Society of North America (RSNA) in Chicago last month.
Kitty Yundt, women’s care consultant for Agfa, said the company had just received from Health Canada a medical device license to sell the CR unit for mammography in Canada. Agfa CR mammography systems such as the CR 85-X can be configured to support mixed use between mammography and general radiology to integrate the workflows. Another mammography solution up for 510(k) clearance is the CR 35-X single plate digitizer for decentralized use. Yundt said the company hopes to have approval in the United States by the second quarter of 2008.
Offering a PACS solution for mammography, Agfa launched Impax Mammography Suite for imaging, workflow and reporting needs of diagnostic and screening mammography. It includes new clinical applications and server-based 3D tools such as maximum intensity projection, multi-planner reformat and volume 3D. The introduction was one of seven Impax suite versions.
Agfa also showcased its Drystar Axys tabletop imager, which introduced earlier this year, is now available. The imager features two trays for two sizes of film, including 14-x 17-inch film. It offers 508 dpi resolution and is suitable for mammography, CT, MRI and CR.
As for what might be next, Yundt said “tomosynthesis is a big thing going forward.”