Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Uni…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identifiers
- 510(k) Number
- K211291 FDA 510(k)
- FDA Product Code
- PGW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cube Navigation System is classified as an Ear, Nose, and Throat Stereotaxic Instrument, designed for precise navigation and guidance in neurosurgical procedures. It integrates components such as the VirtuEye V2, Navigation Sensor NanoRest, and Navigation Unit Cube 4D to provide real-time spatial tracking and imaging support for targeted interventions.
This system is supplied as a reusable medical device and is intended for use in sterile environments within neurosurgical settings. It includes MRI-compatible components and is authorised under FDA 510(k) clearance and MDR compliance. The device operates within Class II regulatory classification and is distributed by Fiagon GmbH, based in Hennigsdorf, Germany.
Frequently asked questions
What types of neurosurgical procedures is the Cube Navigation System designed to assist with, and how does it provide guidance?
The Cube Navigation System is specifically designed for neurosurgical procedures to provide precise navigation and guidance. It integrates components like the VirtuEye V2 and Navigation Sensor NanoRest to offer real-time spatial tracking and imaging support. This allows surgeons to perform targeted interventions with enhanced accuracy, particularly in complex areas of the brain or skull.
Is the Cube Navigation System reusable, and what considerations should be taken for its use in sterile environments?
Yes, the Cube Navigation System is supplied as a reusable medical device. Since it is intended for use in sterile environments within neurosurgical settings, proper cleaning, sterilization, and maintenance protocols must be followed to ensure patient safety and device functionality. The system’s reusable nature requires adherence to strict infection control measures.
Does the Cube Navigation System include MRI-compatible components, and how does this benefit neurosurgeons?
Yes, the Cube Navigation System includes MRI-compatible components, which allows it to be used safely alongside MRI imaging during neurosurgical procedures. This integration enables seamless navigation and imaging guidance, improving precision and reducing the need for additional interventions or repositioning of the patient.
What regulatory pathways has the Cube Navigation System undergone, and what does this mean for its use in clinical settings?
The Cube Navigation System has been authorized under both FDA 510(k) clearance and MDR compliance, indicating it meets regulatory standards for safety and effectiveness. This means it has undergone rigorous review by regulatory bodies to ensure its suitability for use in clinical neurosurgical settings, providing confidence in its performance and reliability.
How is the Cube Navigation System distributed, and who should clinicians contact for further inquiries?
The Cube Navigation System is distributed by Fiagon GmbH, based in Hennigsdorf, Germany. For further inquiries, clinicians can reach out to Dirk Mucha, who serves as the contact person at the company’s address: Neuendorfstr. 23b, 16761 Hennigsdorf, Germany.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211291 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (2)
- FDA 510(k) K211291 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026