Display manufacturer Totoku Electric has received Food and Drug Administration 510(k) clearance for the use of its ME511L five-megapixel flat-panel display in the diagnostic reading of mammography images in PACS applications.
Totoku received 510(k) clearance in April for use of the display to read mammography images as part of a PACS network, according to U.S. Electronics, which distributes Totoku monitors in the U.S. Totoku has submitted additional documentation to secure clearance for use of the system with a stand-alone full-field digital mammography system, according to the company.
By AuntMinnie.com staff writersJune 24, 2004
Related Reading
U.S. Electronics gets 510(k), June 3, 2004
U.S. Electronics gets clearance for new display, April 26, 2004
FDA clears Totoku monitor, August 10, 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)






