CardiacGeneralAI / InformaticsDevices & AI clearances

Cleerly Plaque AI Coronary CTA Software Gets FDA 510(k)

U.S. FDA2w ago

FDA cleared Cleerly's coronary CT angiography AI software for plaque analysis via the 510(k) pathway.

  • Device name: Cleerly Plaque.
  • Clearance pathway: 510(k); product code QIH (radiological computer-assisted detection/diagnosis software for cardiovascular disease).
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