Musculoskeletal (MSK)Devices & AI clearances

FDA clears SkeletonPlanner for bone image processing

U.S. FDA1w ago

FDA 510(k) clearance for SkeletonPlanner (UPlanner B.V. - Presurgeo), a radiological image processing system. Product code QIH; reviewed by the Radiology committee.

  • Device is classified under product code QIH (radiological image processing system).
  • Cleared via 510(k) pathway; reviewed by the FDA Radiology committee.
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