GeneralDevices & AI clearances

FDA Clears Rivanna Medical's Accuro 3S Ultrasound System via 510(k)

U.S. FDA1w ago

FDA 510(k) clearance for Rivanna Medical's Accuro 3S ultrasound system (product code IYO). The Radiology committee reviewed the device.

  • Clearance pathway was a traditional 510(k).
  • Product code IYO classifies the device as an ultrasound imaging system.
  • The application was reviewed by the FDA's Radiology device committee.

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