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.
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