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UroNav (Version 3.0)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182561

by Invivo Corporation

Identifiers

510(k) Number
K182561 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The UroNav (Version 3.0) is a Picture Archiving and Communication System (PACS) classified under product code LLZ, designed for radiology applications. It functions as an X-ray imaging system integrated with navigation capabilities to assist in precise medical imaging procedures, particularly in urological and interventional radiology settings.

This device is supplied as a Class II medical system, cleared under FDA 510(k) and in compliance with the Medical Device Directive (MDD). It is intended for use in radiology departments, where it supports real-time imaging and navigation for procedures such as biopsies, ablations, or other interventional techniques. The system requires proper installation, calibration, and adherence to manufacturer instructions for use, with no explicit indication of single-use or sterility requirements.

Frequently asked questions

What types of medical procedures is the UroNav (Version 3.0) designed to assist with in real-time imaging?

The UroNav (Version 3.0) is specifically designed to support real-time imaging and navigation for interventional radiology and urological procedures. This includes assisting with biopsies, ablations, and other precise interventions where accurate imaging guidance is critical. Its integration of X-ray imaging with navigation capabilities helps clinicians perform these procedures with enhanced precision.

Is the UroNav (Version 3.0) intended for single-use or can it be reused in a clinical setting?

The UroNav (Version 3.0) is not described as a single-use device. As a Class II medical system, it is intended for repeated use in radiology departments, provided it is properly maintained, calibrated, and adhered to the manufacturer’s instructions for use. There are no explicit sterility requirements mentioned, so reuse is implied under standard clinical protocols.

How is the UroNav (Version 3.0) regulated, and what does that mean for its use in hospitals?

The UroNav (Version 3.0) is cleared under the FDA’s 510(k) pathway as a Class II medical device and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in radiology departments. Hospitals must follow the manufacturer’s instructions for installation, calibration, and operation to maintain compliance and optimal performance.

Does the UroNav (Version 3.0) require any special handling or storage conditions?

The provided data does not specify special handling or storage conditions for the UroNav (Version 3.0). However, as a Class II medical imaging system, it should be stored in a clean, controlled environment to protect it from physical damage or contamination. Proper installation and adherence to the manufacturer’s guidelines are essential for ensuring reliable operation.

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: INVIVO URONAV QUICK REFERENCE MANUAL Pdf Download, Invivo UroNav (Version 3.0) | allmed.wiki, UroNav (Version 3.0) (K182561) — FDA 510 (k) | Innolitics, PDF Invivo Uronav Quick Reference Manual

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Invivo Corporation

Sources (2)

  • FDA 510(k) K182561 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026