CardiacNuclear / MolecularDevices & AI clearances

FDA Clears INVIA 4DM via 510(k) Radiology Review

U.S. FDA1w ago

U.S. FDA cleared INVIA's 4DM under the 510(k) pathway; the radiology committee reviewed the device under product code QIH.

  • Regulator: U.S. FDA; pathway: 510(k).
  • Device: 4DM; applicant: INVIA, LLC; committee: radiology; product code: QIH.
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