Neuro / Head & NeckAI / InformaticsDevices & AI clearances

FDA clears Ischemaview's Rapid ICH v4.0 for CT intracranial hemorrhage detection

U.S. FDAOct 9

FDA cleared Ischemaview's Rapid ICH v4.0, an AI software for detecting intracranial hemorrhage on CT, via the 510(k) pathway.

  • FDA clearance under 510(k) premarket notification (product code QAS).
  • Device is manufactured by Ischemaview, Inc. and intended for detection of intracranial hemorrhage on CT images.
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