Cleared Traditional

Intra-Operative Positioning System (IOPS?)

K243842 · Centerline Biomedical, Inc. · Cardiovascular
Mar 2025
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K243842 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS?), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Centerline Biomedical, Inc. (Warrensville Heights, US). The FDA issued a Cleared decision on March 6, 2025, 83 days after receiving the submission on December 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K243842 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date March 06, 2025
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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