510(k) clearance

Intra-Operative Positioning System (IOPS) and IOPS Visionary System

FDA 510(k) source

510(k) number

K263016

Applicant

Centerline Biomedical

Decision date

Oct 1, 2026

Date received

Aug 28, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

DQK

Device type

Computer, Diagnostic, Programmable

Device class

Class II

Regulation

21 CFR 870.1425

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Warrensville Heights, OH, US