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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![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&fit=crop&h=112&q=70&w=112)





