Smart Soft Healthcare AD

3 AI-enabled medical devices from Smart Soft Healthcare AD on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-04-01K254015CoLumbo C-SpineSmart Soft Healthcare ADRadiology
2025-05-28K250367CoLumboXSmart Soft Healthcare ADRadiology
2022-06-23K220497CoLumboSmart Soft Healthcare ADRadiology

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