• Core Function: AI-powered Computer-Aided Detection (CADe) and Diagnosis (CADx) for 2D mammography screening.
• Company: Lunit Inc. (Founded 2013, publicly traded on KOSDAQ: 328130).
• Ideal For: High-volume breast screening centers, general radiology practices, and health systems using 2D mammography (FFDM).
• Pricing: Contact Sales / Not publicly disclosed (often bundled via PACS or hardware vendors).
• Integration: PACS/modality agnostic via DICOM (Secondary Capture or GSPS); available via marketplaces (Blackford, Ferrum) or vendor partnerships (GE, Fujifilm, Philips).
• Regulatory / Compliance: FDA 510(k) Cleared (K211678), CE Mark (MDR), UKCA.
• Validation: One of the most academically validated algorithms in the space. A notable independent study published in JAMA Oncology (2020) showed it outperformed several other commercial algorithms in sensitivity and specificity.

Verdict: 🟢 Strong Fit for Stated Use Case

Logic for Verdict: 🟢 = Established deployment, FDA cleared, robust peer-reviewed evidence (e.g., JAMA Oncology), and standard PACS integrations make this a low-risk, high-utility choice for 2D mammography workflows.

Disclaimer

Doxiverse provides independent, informational content for healthcare professionals. Tool descriptions and insights reflect Doxiverse’s editorial analysis and professional opinion based on publicly available information at the time of publication. Content is not medical advice, does not constitute endorsement, and may change as products evolve. Users should independently verify all clinical, regulatory, security, and pricing details directly with vendors and relevant authorities.