GeneralDevices & AI clearances

GE Voluson Expert 18, 20, 22 ultrasound systems gain FDA 510(k) clearance

U.S. FDA1w ago

FDA clears GE Medical Systems' Voluson Expert 18, 20, and 22 diagnostic ultrasound systems via 510(k) pathway.

  • The Voluson Expert series includes three models (18, 20, 22).
  • The clearance was under product code IYN for diagnostic ultrasound transducers.
  • No specific performance claims or intended use changes were released with the clearance notice.
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