GeneralDevices & AI clearances

FDA clears S.M.A.I.O's KBA3D image processing software

U.S. FDA3w ago

FDA granted 510(k) clearance to S.M.A.I.O for KBA3D (v2.4.0), a radiological image processing system (product code LLZ).

  • Cleared under FDA product code LLZ (System, Image Processing, Radiological).
  • The software is intended for radiological image processing, though specific clinical applications were not detailed in the clearance notice.
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