Nuclear / MolecularDevices & AI clearances

FDA Clears Hermes Medical Solutions' Affinity PET System

U.S. FDA2w ago

The FDA has cleared the Affinity PET system (Hermes Medical Solutions) via 510(k) with product code QIH, indicating a positron emission tomography device. Radiology committee reviewed.

  • FDA 510(k) clearance assigned product code QIH (Positron Emission Tomography System).
  • Reviewed by FDA's Radiology committee.
  • Manufacturer: Hermes Medical Solutions AB.

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.