GeneralDevices & AI clearances

DRTECH EXTRON 3 and EXTRON 6 fluoroscopic x-ray systems cleared by FDA

U.S. FDA2w ago

The FDA has cleared DRTECH Corporation's EXTRON 3 and EXTRON 6, image-intensified fluoroscopic x-ray systems, via the 510(k) pathway.

  • The EXTRON 3 and EXTRON 6 are classified as image-intensified fluoroscopic x-ray systems (product code OWB).
  • The 510(k) clearance indicates the devices are substantially equivalent to existing legally marketed fluoroscopic systems.
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