GeneralBody / AbdominalDevices & AI clearances

Esaote's I-Genius Ultrasound System Receives FDA 510(k) Clearance

U.S. FDA2w ago

FDA has cleared Esaote's I-Genius diagnostic ultrasound system via the 510(k) pathway for general imaging use.

  • The clearance was granted under the 510(k) premarket notification pathway.
  • The device is classified as an ultrasonic pulsed echo imaging system (product code LNH).
  • Esaote S.p.A. is the applicant; the FDA's Radiology committee reviewed the submission.
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