GeneralDevices & AI clearances

FDA posts 510(k) clearance for Argus Cognitive ReVISION 2 radiology device

U.S. FDA1w ago

The U.S. FDA has posted a 510(k) clearance for ReVISION 2 from Argus Cognitive, Inc., listing it as a radiology device under product code QIH.

  • Regulatory pathway: FDA 510(k), radiology committee.
  • Device applicant: Argus Cognitive, Inc.; product code QIH.
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