510(k) K263016

Intra-Operative Positioning System (IOPS) and IOPS Visionary System by Centerline Biomedical — Product Code DQK

K263016 is an FDA 510(k) premarket notification submitted by Centerline Biomedical for the device "Intra-Operative Positioning System (IOPS) and IOPS Visionary System". The FDA issued a decision of Substantially Equivalent on Oct 1, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Centerline Biomedical has 7 other 510(k) clearances on record.