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

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).