Musculoskeletal (MSK)GeneralAI / InformaticsDevices & AI clearances

BoneVue 510(k) Clearance by FDA

U.S. FDA1w ago

FDA cleared BoneVue (Curvebeam AI/Curvebeam, LLC) via the 510(k) premarket pathway.

  • Device: BoneVue
  • Applicant: Curvebeam AI / Curvebeam, LLC
  • Regulatory pathway: FDA 510(k) clearance, radiology committee, product code KGI

Automated summary

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