FDA clears Siemens Opdima unit

Siemens Medical Systems has received 510(k) clearance from the Food and Drug Administration for its Opdima digital spot mammography unit. Opdima is based on charge-coupled device (CCD) technology and retrofits to the Iselin, NJ, vendor's Mammomat 3000 mammography system. It has a field-of-view of 49 x 85 mm, which Siemens claims is the largest in the industry among digital spot devices. Siemens launched Opdima in Europe in April (SCAN 4/30/97).