510(k) K262383

LumenCare Azure by Nucletron B.V. — Product Code JAQ

K262383 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "LumenCare Azure". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron B.V. has at least 10 other 510(k) clearances on record.