510(k) K210692

DigitalDiagnost by Philips Medical Systems Dmc GmbH — Product Code KPR

K210692 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "DigitalDiagnost". The FDA issued a decision of Substantially Equivalent on April 2, 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.