510(k) K200899

Quantib AI Node by Quantib B.V. — Product Code LLZ

K200899 is an FDA 510(k) premarket notification submitted by Quantib B.V. for the device "Quantib AI Node". The FDA issued a decision of Substantially Equivalent on June 15, 2020. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Quantib B.V. has at least 10 other 510(k) clearances on record.