Interventional (IR)GeneralDevices & AI clearances

FDA Clears CIVCO Align Cover and Pad Guidance Tool via 510(k)

U.S. FDA1w ago

FDA cleared CIVCO Medical Instruments’ Align Cover and Pad Guidance Tool via the 510(k) pathway; the radiology device is listed under FDA product code ITX.

  • Applicant: CIVCO Medical Instruments Co., Inc.; FDA committee: Radiology.
  • Product code: ITX.

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