Musculoskeletal (MSK)AI / InformaticsDevice clearance

ARTHUR AI software cleared for rheumatoid arthritis assessment

FDA 510(k) — Radiology devices2w ago

FDA cleared ARTHUR (ROPCA ApS), software that uses artificial intelligence to assist in assessing joint damage in rheumatoid arthritis via radiography. (exact predicate or performance metrics not reported in source)

  • 510(k) clearance for ARTHUR, a radiology software device from ROPCA ApS (product code IYO).
  • Designed as an aid in evaluation of radiographic joint damage associated with rheumatoid arthritis.
  • Specific predicate device and standalone sensitivity/specificity data were not provided in the publicly available clearance summary.
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