FDA Grants Carestream 510(k) Clearance for Tomosynthesis Technology

The FDA has cleared Carestream’s digital tomosynthesis technology for its DRX-Evolution Plus system, a digital radiography platform that can conduct general radiographic exams.

The upgradeable option uses a single sweep of X-ray exposures to produce data from low-dose X-ray images of the same organ taken from different angles at the same exposure.

Digital tomosynthesis is similar to computed tomography scans in that it can improve visibility by creating cross-sectional images of an organ.