gudid Primary ID: MC-3

IOPS Visionary System (UDI MC-3)

Manufactured by Centerline Biomedical, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The IOPS Visionary System (Model/Catalog Number: MC-3) is a medical device manufactured by Centerline Biomedical, Inc.. This product is indexed under FDA Product Code / Category Classification DQK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MC-3
Product Code / EMDN: DQK
Device Name: The IOPS Visionary system displays the position and orientation of sensor-equipped IOPS guidewires and IOPS catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously-acquired scan data (CT). IOPS Visionary tracks the location and orientation of the sensors in real time, superimposing navigation of the IOPS Catheter and IOPS Guidewire to the patient's vascular map. The system consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact, reusable, multi-patient use device. The associated accessories are single use devices provided sterile (EtO). The IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Database Sync Date: 2026-08-09 09:13:48

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of IOPS Visionary System?

The registered manufacturer of record for IOPS Visionary System is Centerline Biomedical, Inc..

What is the Primary UDI-DI identifier for IOPS Visionary System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MC-3.

What classification code is assigned to this device?

This device is registered under product classification code DQK.

Similar Classification Devices (DQK)

Other Devices by Centerline Biomedical, Inc.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint