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Intra-Operative Positioning System (IOPS)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243842

by Centerline Biomedical, Inc.

Identifiers

510(k) Number
K243842 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Intra-Operative Positioning System (IOPS) is a 3D surgical navigation and visualization device designed for endovascular procedures. It provides real-time, three-dimensional imaging of patient anatomy to assist in precise catheter and device placement during interventions.

IOPS is used in the operating room to reduce radiation exposure by enabling fluoroscopy-independent navigation. Supplied as a software-based system requiring integration with existing CT scan data, it is not classified as a single-use or reusable device under its specifications. The system holds an FDA 510(k) clearance (K243842) under the product code DQK, with no explicit MRI safety or sterility requirements stated.

Frequently asked questions

What types of procedures is the IOPS® designed to assist with, and how does it reduce radiation exposure for patients and staff?

The IOPS® is specifically designed for endovascular procedures, where precise catheter and device placement are critical. It reduces radiation exposure by enabling fluoroscopy-independent navigation, allowing clinicians to visualize patient anatomy in real-time using pre-loaded CT scan data instead of continuous X-ray imaging. This minimizes both patient and staff radiation doses during interventions.

Is the IOPS® a single-use or reusable device, and what are the key considerations for its maintenance or storage?

The IOPS® is not classified as a single-use or reusable device under its specifications. Since it is a software-based system integrated with existing CT scan data, its primary maintenance considerations involve ensuring compatibility with updated imaging software, hardware updates for the operating room equipment, and proper calibration of the system. Storage requirements are minimal, as it relies on digital data and hardware components that do not degrade over time like consumables.

What regulatory pathway was followed for the FDA clearance of the IOPS®, and what does the product code DQK indicate about its intended use?

The IOPS® received FDA clearance through a traditional 510(k) pathway, specifically under the product code DQK, which categorizes it within cardiovascular devices. This clearance was granted after demonstrating substantial equivalence to a predicate device, focusing on its role in improving surgical navigation and visualization for endovascular procedures. The product code does not define clinical indications but reflects how the submission was filed with the FDA.

Does the IOPS® require any special handling for sterility or MRI safety, and how is it supplied to the clinical setting?

The IOPS® does not have explicit sterility requirements stated in its specifications, as it is a software-based system integrated with existing hardware in the operating room. It is not designed for direct patient contact or as a sterile consumable. The system is supplied as a complete software solution requiring integration with pre-existing CT scan data and compatible imaging equipment, with no additional packaging or sterilization steps needed beyond standard IT and hardware maintenance protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IOPS Technology | Centerline Biomedical, IOPS Software | Centerline Biomedical, Intra-Operative Positioning System | Centerline Biomedical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Centerline Biomedical, Inc.

Sources (1)

  • FDA 510(k) K243842 24 fields · synced Sep 19, 2026