CardiacDevices & AI clearances

FDA Clears GE CardIQ Suite Cardiac Analysis Software

U.S. FDAJul 21

FDA clears CardIQ Suite (GE Medical Systems) for cardiac CT analysis via 510(k). The radiology committee reviewed under product code JAK.

  • The CardIQ Suite is a cardiac computed tomography analysis platform.
  • 510(k) premarket notification reviewed by the FDA’s radiology committee.
  • Manufacturer: GE Medical Systems SCS; product code JAK.
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