510(k) K162025

IntelliSpace Portal Platform by Philips Medical Systems Nederlands B.V. — Product Code LLZ

K162025 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederlands B.V. for the device "IntelliSpace Portal Platform". The FDA issued a decision of Substantially Equivalent on October 18, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Philips Medical Systems Nederlands B.V. has at least 7 other 510(k) clearances on record.