Musculoskeletal (MSK)Devices & AI clearances

FDA Clears Replasia's HipStudio Analysis Software

U.S. FDA2w ago

FDA cleared HipStudio Analysis (Replasia BV), a radiological image processing software, via the 510(k) pathway.

  • Cleared through the FDA 510(k) premarket notification pathway.
  • Classified as radiological image processing software (product code LLZ).
  • Manufacturer: Replasia BV.
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