510(k) K221270

EchoNavigator R4.0 by Philips Medical Systems Nederland B.V. — Product Code LLZ

K221270 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "EchoNavigator R4.0". The FDA issued a decision of Substantially Equivalent on May 31, 2022. 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.