510(k) K223918

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub by Philips Medical Systems Nederland B.V. — Product Code DQK

K223918 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub". The FDA issued a decision of Substantially Equivalent on Jun 8, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.