Siemens files PMA for FFDM system

Siemens Medical Solutions of Malvern, PA, has filed a premarket approval (PMA) application with the Food and Drug Administration for its first full-field digital mammography (FFDM) system, Mammomat NovationDR.

The first NovationDR prototype unit is being used for an ongoing clinical study at the Iris Cantor Center for Breast Imaging at the University of California, Los Angeles. The study will compare the content and image quality of analog and digital images taken at the same level of radiation exposure, Siemens said.

NovationDR is based on Siemens’ Novation 3000 mammography system, but uses a 25 x 29-cm flat-panel digital detector based on amorphous selenium.

By AuntMinnie.com staff writers
April 7, 2003

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Siemens installs prototype FFDM at UCLA, January 15, 2003

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