Neuro / Head & NeckAI / InformaticsDevices & AI clearances

FDA clears RadioViewAI for automated brain MRI analysis

U.S. FDA2w ago

The FDA has cleared RadioViewAI, a software device by NeurocareAI, via the 510(k) pathway for automated analysis of brain MRI images.

  • RadioViewAI is regulated as a radiological computer-assisted diagnostic (CADx) device under product code LLZ.
  • The application was reviewed by the FDA's Radiology committee.
  • The specific intended use and performance data were not disclosed in the clearance summary.
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