510(k) K212837

ProxiDiagnost N90 by Philips Medical Systems Dmc GmbH — Product Code JAA

K212837 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "ProxiDiagnost N90". The FDA issued a decision of Substantially Equivalent on September 21, 2021. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.