510(k) K242133

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) by Centerline Biomedical, Inc. — Product Code DQK

K242133 is an FDA 510(k) premarket notification submitted by Centerline Biomedical, Inc. for the device "Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Centerline Biomedical, Inc. has at least 6 other 510(k) clearances on record.