GeneralDevices & AI clearances

FDA clears Xingaoyi's MagicScan-1.5 and GreenMR Serenity 1.5T MRI systems

U.S. FDA3w ago

U.S. FDA cleared Xingaoyi Medical Equipment's MagicScan-1.5 and GreenMR Serenity 1.5T MRI systems via the 510(k) pathway; radiology product code LNH.

  • Cleared through the FDA 510(k) pathway under radiology product code LNH.
  • Applicant and manufacturer is Xingaoyi Medical Equipment Co., Ltd.
  • Includes two 1.5T systems: MagicScan-1.5 and GreenMR Serenity 1.5T.

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