Neuro / Head & NeckDevices & AI clearances

FDA Clears Quicktome Software Suite for Neuroimaging

U.S. FDA1w ago

The FDA cleared Omniscient Neurotechnology's Quicktome Software Suite via 510(k) as a radiological image processing device (product code QIH).

  • FDA cleared via the 510(k) pathway.
  • Assigned product code QIH for radiological image processing.
  • Applicant: Omniscient Neurotechnology Pty, Ltd.
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