GeneralAI / InformaticsDevices & AI clearances

FDA 510(k) Clearance for Vista AI Scan (Radiology Image Processing System)

U.S. FDAOct 7

FDA has cleared Vista AI Scan, a radiological image processing system (product code LNH) from Vista AI, Inc., via the 510(k) pathway.

  • Device classified under FDA product code LNH (Radiological Image Processing System).
  • Reviewed by FDA’s Radiology Devices Advisory Committee.
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