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EverFortune.AI Secures World’s First FDA PCCP Approval for Radiotherapy AI "Seg Pro V3"

EverFortune.AI (長佳智能) announced yesterday that its AI-powered medical software, the Radiotherapy Organ Auto-Contouring System (Seg Pro V3), has been granted US FDA 510(k) clearance. Notably, it is the first product globally in the "Radiotherapy Image Processing Software" (QKB) category to be approved under the FDA’s Predetermined Change Control Plans (PCCP).

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Jan 30, 2026
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