Carestream Health of Rochester, NY, has received approval from the U.S. Food and Drug Administration (FDA) for its high-resolution computed radiography (CR) full-field digital mammography (FFDM) system.
Carestream's DirectView CR Mammography feature allows users to capture mammography images digitally, using a healthcare provider's existing mammography x-ray unit, according to Carestream. Once the FDA approves the final product labeling, the company will begin immediate commercial distribution of the system in the U.S., Carestream said.
The company's announcement comes the same day that the FDA changed the classification for digital mammography devices from class III or high-risk devices, which require a premarket approval application, to class II or medium-risk devices, which only require a 510(k) submission.
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