GeneralDevices & AI clearances

FDA Clears Gemss Healthcare's XLITE Device via 510(k)

U.S. FDA2w ago

FDA 510(k) clearance for XLITE, a radiology device from Gemss Healthcare Co., Ltd., classified under product code IZL.

  • Cleared through the FDA 510(k) pathway.
  • Classified as product code IZL (Radiology).
  • Applicant: Gemss Healthcare Co., Ltd.
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