GeneralDevices & AI clearances

FDA Clears Fujifilm FCT iStream Phase 2 CT System

U.S. FDA1w ago

FDA cleared Fujifilm's FCT iStream Phase 2 computed tomography system via the 510(k) pathway. The device is classified under product code JAK for computed tomography x-ray systems.

  • Classified as product code JAK (computed tomography x-ray system).

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.