Siemens Medical Systems has received 510(k) clearance from the FDA for diagnostic use of its Opdima digital spot mammography module.
The approval will enable mammographers to use Opdima to make primary diagnoses of masses or calcifications, according to the Iselin, NJ, vendor. Opdima already is cleared for use during stereotactic biopsy, spot localization, and for spot imaging of suspect areas.
Opdima is based on a charge-coupled device (CCD) digital detector and is used with Siemens' Mammomat 3000 Nova mammography system. The device features a resolution of 20 line pairs per millimeter, and a 49-x-85-mm field of view.
By AuntMinnie.com staff writersMarch 23, 2001
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