Interventional (IR)Devices & AI clearances

SpaceOAR Flex System Receives FDA 510(k) Clearance

U.S. FDA1w ago

FDA 510(k) clearance for Boston Scientific’s SpaceOAR Flex System (product code OVB, radiology panel).

  • Clearance pathway: 510(k).
  • Device classification: product code OVB, radiology panel.
  • Manufacturer: Boston Scientific Corporation.
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