GeneralDevices & AI clearances

FDA Clears Remedi's REMEX-T(K)100C via 510(k) Pathway

U.S. FDA1w ago

FDA grants 510(k) clearance to Remedi, Inc. for the REMEX-T(K)100C radiology device (product code IZL).

  • Clearance pathway: FDA 510(k), reviewed by the Radiology committee.
  • Device: REMEX-T(K)100C from Remedi, Inc.
  • Product code IZL (radiology device).
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