FDA clears Sony mammography imager for FFDM

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The FDA has granted 510(k) clearance for Sony Medical’s FilmStation mammography film imager, model UP-DF750, for full-field digital mammography (FFDM) applications. 

The Park Ridge, N.J.-based company said its UP-DF750 optimizes image workflow in both general radiography and mammography applications. The multi-format film imager allows radiology departments to focus on diagnoses.

Sony said its imager offers a variety of film formats with two online media trays, capable of covering any choice of film media type to cover all radiography applications. The print quality fulfils the mammography requirements in terms of optical density and resolution. 

Reproducing prints of 604 dpi, with a maximum of 3.8+ using high-density film, the company said its UP-DF750 is suitable for mammography imaging, delivering multiple film sizes—8 x 10, 10 x 12, 11 x 14 and 1 4x 17 inches for various modalities—to provide both mammography imaging and copies for patient referral.