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3di

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093703

by Shina Systems , Ltd.

Identifiers

510(k) Number
K093703 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 3Di Mammo Viewer is a medical imaging workstation designed for breast imaging centers, classified under the nomenclature for radiographic image display devices (Product Code: LLZ). It enables the visualization of both 2D and 3D mammographic images from multiple vendor modalities, facilitating enhanced diagnostic flexibility and integration with computer-aided detection (CAD) solutions.

This device is supplied as a software-based workstation solution, intended for use in radiology departments, teleradiology centers, or hospital imaging suites. It operates on standard computing platforms, including workstations, data centers, or cloud environments, and is not classified as single-use or reusable. The device holds FDA 510(k) clearance (K093703) under the Radiology Advisory Committee, with no specified MRI safety classification. Storage and deployment requirements align with standard IT infrastructure for medical imaging software.

Frequently asked questions

What types of mammographic images can the 3Di Mammo Viewer display, and how does it support diagnostic flexibility?

The 3Di Mammo Viewer is designed to visualize both 2D and 3D mammographic images from multiple vendor modalities, enabling radiologists to compare and analyze scans from different systems. This interoperability enhances diagnostic flexibility by allowing seamless integration with computer-aided detection (CAD) solutions, improving accuracy and workflow efficiency in breast imaging centers.

Is the 3Di Mammo Viewer a standalone hardware device, or does it require a specific computing setup?

The 3Di Mammo Viewer is a software-based workstation solution that operates on standard computing platforms, such as dedicated workstations, data centers, or cloud environments. It does not require proprietary hardware, making it adaptable to existing IT infrastructure in radiology departments, teleradiology centers, or hospital imaging suites.

How is the 3Di Mammo Viewer classified for regulatory purposes, and which advisory committee was involved in its approval?

The 3Di Mammo Viewer falls under the Product Code LLZ, categorized as a radiographic image display device. It received FDA 510(k) clearance (K093703) under the Radiology Advisory Committee (RA), with a decision code of SESE (Substantially Equivalent). The approval process was traditional, meaning it demonstrated equivalence to a legally marketed predicate device.

Can the 3Di Mammo Viewer be used in environments where MRI safety is a concern, and how is it deployed?

The 3Di Mammo Viewer does not have an MRI safety classification, meaning it is not intended for use in MRI environments. Deployment follows standard IT infrastructure guidelines for medical imaging software, allowing installation on workstations, servers, or cloud platforms in radiology departments, teleradiology centers, or hospital imaging suites.

Is the 3Di Mammo Viewer reusable or single-use, and what maintenance considerations should be noted?

The 3Di Mammo Viewer is not classified as single-use or reusable, as it is a software-based solution installed on hardware infrastructure. Maintenance aligns with standard IT practices for medical imaging software, including updates, system backups, and compliance with institutional IT policies to ensure optimal performance and data security.

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: Shina Systems | Medical Image Management and Advanced Visualization, Medical Image Management and Advanced Visualization by Shina Systems, Shina Systems | Solutions | 3Di Image Management and Advanced Visualization, Shina Systems | Medical Image Management and Advanced Visualization

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shina Systems , Ltd.

Sources (1)

  • FDA 510(k) K093703 24 fields · synced Sep 19, 2026