Multi Modality Viewer
by Vital Images, Inc. 510(k)
Active
510(k) K163574
Overview
The Multi Modality Viewer is a software application designed for the examination and manipulation of medical images from multiple imaging modalities, including MRI, CT, and other radiologic sources. It enables clinicians to review, compare, and analyze image series side-by-side, facilitating comprehensive diagnostic assessments. The device integrates with advanced visualization platforms to enhance workflow efficiency and support multi-dimensional data evaluation.
This software is supplied as part of the Vitrea Advanced Visualization system and is intended for use in clinical radiology settings. It operates as a standalone module within the Vitrea platform, requiring no additional sterility or physical handling, as it is a non-invasive, digital tool. The device is classified under FDA 510(k) clearance (K163574) and is intended for use with radiological imaging systems, adhering to regulatory standards for image processing systems. No specific sterility or single-use requirements apply, as it is a reusable software application.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163574 | Date26 Jan 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vital Images, Inc.
Questions
What is the Multi Modality Viewer used for?
The Multi Modality Viewer is a software module designed to enable clinicians to examine, compare, and analyze medical images from multiple modalities—such as MRI, CT, and other radiologic sources—in a single interface. It supports comprehensive diagnostic assessments by allowing side-by-side visualization of image series, which helps radiologists evaluate multi-dimensional data more efficiently. This tool is integrated into the Vitrea Advanced Visualization system and is specifically intended for use in clinical radiology settings.
How is the Multi Modality Viewer supplied and does it require sterility?
The Multi Modality Viewer is supplied as part of the Vitrea Advanced Visualization system and operates as a standalone software module. Since it is a digital tool, no physical handling or sterility requirements apply. It is a reusable application, meaning it does not need to be discarded after use or maintained under sterile conditions.
Is the Multi Modality Viewer single-use or reusable?
The Multi Modality Viewer is a reusable software application. As a digital tool, it is designed for repeated use within the Vitrea Advanced Visualization system without any limitations on usage cycles. This distinguishes it from physical medical devices that may require single-use protocols.
What imaging modalities does the Multi Modality Viewer support?
The Multi Modality Viewer is compatible with MRI, CT, and other radiologic imaging modalities. Its primary function is to facilitate the side-by-side comparison and analysis of image series from these sources, enabling clinicians to perform more thorough diagnostic evaluations by integrating data from different imaging techniques.
How does the Multi Modality Viewer integrate with existing systems?
The Multi Modality Viewer is integrated as a standalone module within the Vitrea Advanced Visualization system. It is designed to enhance workflow efficiency by providing advanced visualization capabilities for radiologic images, ensuring seamless compatibility with existing radiological imaging systems while maintaining regulatory standards for image processing.