510(k) K212186

Philips Radiology Smart Assistant by Philips Medical Systems Dmc GmbH — Product Code KPR

K212186 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Philips Radiology Smart Assistant". The FDA issued a decision of Substantially Equivalent on December 13, 2021. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.