Body / AbdominalDevices & AI clearances

FDA Clears Lucida Medical's Prostate Core Software

U.S. FDA2w ago

FDA cleared Lucida Medical's Prostate Core, a radiological image processing software (product code QIH), via the 510(k) pathway. The clearance supports the device's use in prostate imaging analysis.

  • The device is classified under product code QIH (System, Image Processing, Radiological).
  • Cleared by the FDA's Radiology committee.
  • Applicant is Lucida Medical, Ltd.
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