Interventional (IR)Devices & AI clearances

FDA Clears CAS-One IR Interventional Radiology System from Cascination AG

U.S. FDA2w ago

FDA 510(k) clearance for Cascination AG's CAS-One IR, an interventional radiology system reviewed by the Radiology committee (product code JAK).

  • The FDA cleared the CAS-One IR device from Cascination AG via the 510(k) premarket notification pathway.
  • The device is classified under product code JAK and was reviewed by the Radiology advisory committee.
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