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visor2 System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210109

by Eemagine Medical Imaging Solutions Gmbh

Identifiers

510(k) Number
K210109 FDA 510(k)
FDA Product Code
HAW 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 Visor2 System is a Neurological Imaging Device designed for advanced visualisation of brain structures and vascular anatomy. It integrates high-resolution imaging capabilities to support diagnostic assessments in neurology, particularly for conditions requiring detailed cerebral imaging.

This system is supplied as a reusable medical device, intended for use in clinical settings such as hospitals and imaging centres. It is subject to FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for safety and performance. The device is not classified as MRI-safe or MRI-conditional, and its operational specifications are governed by the manufacturer’s guidelines for proper handling and maintenance.

Frequently asked questions

What clinical specialties would benefit most from using the Visor2 System in their diagnostic workflows?

The Visor2 System is specifically designed for neurologists and imaging centers specializing in cerebral diagnostics. Its advanced visualization capabilities are particularly useful for assessing brain structures and vascular anatomy, making it ideal for conditions requiring detailed neurological imaging, such as stroke evaluation, vascular malformations, or neurodegenerative disease monitoring.

Is the Visor2 System intended for single-use or repeated use in clinical settings?

The Visor2 System is supplied as a reusable medical device, meaning it is engineered for repeated use in clinical environments like hospitals and imaging centers. Proper maintenance and adherence to the manufacturer’s guidelines are required to ensure continued safety and performance.

What regulatory pathways does the Visor2 System follow, and how does this affect its use?

The Visor2 System has undergone FDA 510(k) clearance and complies with MDR (Medical Device Regulation) standards, ensuring it meets stringent safety and performance requirements. This regulatory route confirms its suitability for clinical use in the U.S. and EU markets, though specific country-specific guidelines should still be followed for proper implementation.

Can the Visor2 System be used in conjunction with MRI machines, or are there compatibility concerns?

The Visor2 System is not classified as MRI-safe or MRI-conditional, meaning it should not be used inside an MRI environment. Its operational specifications are governed by the manufacturer’s guidelines, which explicitly outline safe handling and usage restrictions to prevent interference or safety hazards in MRI settings.

How is the Visor2 System supplied, and what should clinicians consider when ordering or maintaining it?

The Visor2 System is supplied as a reusable device intended for clinical settings like hospitals and imaging centers. Clinicians should ensure proper maintenance protocols are followed, as outlined by the manufacturer, to sustain performance and safety. Since it is not single-use, facilities must account for cleaning, calibration, and storage requirements to comply with regulatory standards and operational needs.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eemagine Medical Imaging Solutions Gmbh

Sources (2)

  • FDA 510(k) K210109 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026