GeneralDevices & AI clearances

FDA Clears Samsung's GC85A Fluoroscopic X-ray System

U.S. FDA1w ago

Samsung Electronics obtained FDA 510(k) clearance for its GC85A fluoroscopic x-ray system (product code KPR).

  • The device is classified under product code KPR (image-intensified fluoroscopic x-ray system).
  • Review was conducted by the FDA's Radiology Devices Committee.
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