510(k) K202808

Brainance MD by Advantis Medical Imaging Single Member P.C. — Product Code LLZ

K202808 is an FDA 510(k) premarket notification submitted by Advantis Medical Imaging Single Member P.C. for the device "Brainance MD". The FDA issued a decision of Substantially Equivalent on Oct 14, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Advantis Medical Imaging Single Member P.C. has 1 other 510(k) clearance on record.