GeneralDevices & AI clearances

Fujifilm BA-004CC fluoroscopy system cleared by FDA

U.S. FDA2w ago

FDA clears Fujifilm’s BA-004CC fluoroscopic x-ray system via the 510(k) premarket notification pathway.

  • The device is assigned FDA product code ITX, corresponding to an image-intensified fluoroscopic x-ray system.
  • The submission was reviewed by the FDA’s Radiology advisory committee.
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