510(k) K153351

Quantib Brain 1 by Quantib B.V. — Product Code LLZ

K153351 is an FDA 510(k) premarket notification submitted by Quantib B.V. for the device "Quantib Brain 1". The FDA issued a decision of Substantially Equivalent on June 17, 2016. 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.