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Stereos Workstation

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K113344

by Eos Imaging

Identifiers

510(k) Number
K113344 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 Stereos Workstation is a medical imaging device classified as a Radiographic Image Processing Workstation (FDA Product Code: LLZ). It is designed to acquire, process, and display three-dimensional (3D) radiographic images, enabling detailed visualization and analysis of anatomical structures for diagnostic and surgical planning purposes.

This workstation is intended for use in radiology departments and clinical settings where 3D imaging is required. Supplied as a reusable device, it requires proper calibration and maintenance to ensure accurate image reconstruction. Authorized under FDA 510(k) clearance (K113344) and MDR compliance, it adheres to regulatory standards for radiographic imaging systems. No specific sterility or single-use requirements are noted in the specifications.

Frequently asked questions

What clinical settings is the Stereos Workstation intended for use in, and how does it support diagnostic and surgical planning?

The Stereos Workstation is designed for radiology departments and clinical environments where three-dimensional (3D) radiographic imaging is essential. It acquires, processes, and displays 3D images to enable detailed visualization of anatomical structures, which aids in both diagnostic assessments and surgical planning by providing precise spatial insights.

Is the Stereos Workstation a single-use or reusable device, and what maintenance is required to ensure accurate performance?

The Stereos Workstation is a reusable device, not intended for single-use. To maintain accurate image reconstruction, it requires proper calibration and routine maintenance as outlined in the manufacturer’s guidelines, ensuring consistent diagnostic and planning reliability.

How is the Stereos Workstation regulated, and what does its FDA clearance (K113344) indicate about its compliance?

The Stereos Workstation holds FDA 510(k) clearance (K113344) under the Radiographic Image Processing Workstation category (Product Code: LLZ), classified as substantially equivalent to a predicate device. This clearance confirms it meets regulatory standards for radiographic imaging systems, including safety and performance requirements as determined by the FDA’s review process.

Does the Stereos Workstation have any sterility requirements, and if not, how should it be handled between uses?

The Stereos Workstation does not have sterility requirements as it is a reusable device. Between uses, it should be cleaned and maintained according to the manufacturer’s instructions to prevent contamination and ensure proper functionality for subsequent imaging sessions.

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
Eos Imaging

Sources (2)

  • FDA 510(k) K113344 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026