GeneralDevices & AI clearances

FDA Clears Eizo RadiForce MX247W Diagnostic Monitor

U.S. FDA2w ago

Eizo's RadiForce MX247W diagnostic monitor received FDA 510(k) clearance for radiology image interpretation. It is classified under product code PGY for diagnostic displays.

  • The clearance was granted via the 510(k) pathway, indicating substantial equivalence to a predicate device.
  • The device is regulated under FDA product code PGY for diagnostic radiology displays.
  • Manufacturer: Eizo Corporation.

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