Konica Minolta Medical Imaging USA has received U.S. Food and Drug Administration (FDA) clearance for its Xpress computed radiography (CR) full-field digital mammography (FFDM) system.
The clearance specifically covers the company's CP1M 18 x 24-inch and 24 x 30-inch cassettes and the use of the company's CS-3 control station with its Regius 190 and 210 readers, according to the vendor. Utilizing a cesium bromide phosphor receptor, the mammography upgrade features a 43.75-µm pixel size, mammography image processing algorithms, and specially designed CR mammography cassettes, Konica Minolta said.
Until accreditation of the CR unit is available from any accreditation body, any facility that wants to install and use the system for mammography must apply to the FDA for its Mammography Quality Standards Act (MQSA) Certification Extension Program, the FDA noted.
