gudid Primary ID: SW-1

IOPS Software Application (UDI SW-1)

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 Software Application (Model/Catalog Number: SW-1) 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: SW-1
Product Code / EMDN: DQK
Device Name: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 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 descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospitals PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. 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

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

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Frequently Asked Questions

Who is the primary manufacturer of IOPS Software Application?

The registered manufacturer of record for IOPS Software Application is Centerline Biomedical, Inc..

What is the Primary UDI-DI identifier for IOPS Software Application?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SW-1.

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.

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