510(k) K163250

Longitudinal Brain Imaging (LoBI) application by Philips Medical Systems Nederland B.V. — Product Code LLZ

K163250 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Longitudinal Brain Imaging (LoBI) application". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.