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GeneralAI / InformaticsDevice clearance

FDA Clears RadOncAI's Informai AI-Powered Radiology Image Analysis Software

FDA 510(k) — Radiology devices2w ago

FDA grants 510(k) clearance to RadOncAI's Informai, an artificial intelligence software for automated radiological image analysis (product code MUJ).

  • RadOncAI's Informai software received FDA 510(k) clearance for automated radiological image analysis (product code MUJ).
  • The software uses AI to assist in interpretation of medical images; specific clinical applications are not detailed in this public clearance summary.
  • Cleared via the 510(k) pathway; predicate device not disclosed in the summary.
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