BreastAI / InformaticsDevices & AI clearances

BeamWorks Inc. secures FDA 510(k) clearance for AI-powered CadAI-B Dx

U.S. FDA2w ago

FDA cleared BeamWorks Inc.'s CadAI-B Dx, an AI-based diagnostic software for radiology, via the 510(k) pathway.

  • CadAI-B Dx is classified under product code QDQ (radiological computer-assisted detection/diagnosis system).
  • The device was cleared through the 510(k) pathway with BeamWorks Inc. as the applicant.
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