Nuclear / MolecularDevices & AI clearances

FDA 510(k) Clearance for LumenCare Azure

U.S. FDA1w ago

U.S. FDA grants 510(k) clearance to Nucletron B.V. for LumenCare Azure, a brachytherapy treatment planning system (product code JAQ).

  • The device is a radiation therapy system intended for radionuclide-based treatments.
  • No predicate device or performance data were disclosed in this summary.

Automated summary

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