Medical software developer Atirix Medical Systems of Minneapolis has received word from the Medical Devices Bureau of Health Canada that it can market its QC-Track software in that country.
Clearance came after the bureau ruled that QC-Track does not fall under its jurisdiction as a medical device.
QC-Track is designed to automate quality control reporting and graphing required for devices associated with breast imaging, as well as the management of professional and facility credentials.
The software is sold exclusively through Hologic for quality control on the Bedford, MA-based company's Selenia full-field digital mammography system and related breast imaging modalities and accessories.
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