uOmnispace.CT Medical Image Post-processing Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242624 FDA 510(k)
- FDA Product Code
- QIH 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 uOmnispace.CT Medical Image Post-processing Software is a diagnostic imaging software designed for advanced processing of computed tomography (CT) scans. It enables clinicians to enhance, reconstruct, and analyze CT images to improve diagnostic accuracy and workflow efficiency, supporting applications such as multiplanar reformatting, 3D volume rendering, and quantitative measurements.
This software is supplied as a digital solution for use in radiology departments and clinical imaging settings. It is intended for single-use per session, though the software license may allow repeated use across multiple scans. Authorized under FDA 510(k) clearance and MDR compliance, it operates without MRI safety considerations. No physical sterility or packaging specifications are provided, as it is a software-based solution distributed via digital channels.
Frequently asked questions
What types of CT scan analyses can the uOmnispace.CT software support, and how might it improve my diagnostic workflow?
The uOmnispace.CT software is designed to enhance CT image analysis through advanced post-processing features like multiplanar reformatting, 3D volume rendering, and quantitative measurements. These capabilities help clinicians visualize and assess scans from multiple angles, generate detailed 3D reconstructions for better anatomical understanding, and perform precise measurements—all of which can streamline workflows and improve diagnostic accuracy by providing clearer, more actionable insights.
Is the uOmnispace.CT software reusable across multiple CT scan sessions, or is it intended for single-use?
The software itself is not tied to a single-use model like a physical device. Instead, it operates under a license that allows repeated use across multiple CT scan sessions. This means you can apply the software’s advanced post-processing tools to different scans as needed, making it a flexible tool for radiology departments handling ongoing imaging workflows.
How is the uOmnispace.CT software distributed, and what kind of technical setup is required for use?
The uOmnispace.CT software is distributed exclusively as a digital solution, meaning it is not supplied in physical packaging or with sterility considerations. To use it, your radiology department will need compatible IT infrastructure to install and run the software, as well as access to CT scan data compatible with its post-processing capabilities. The manufacturer, Shanghai United Imaging Healthcare, would provide specific technical requirements and support for integration.
Does the uOmnispace.CT software have any restrictions related to MRI safety, or is it designed for use in mixed imaging environments?
The uOmnispace.CT software does not involve MRI safety considerations, as it is a standalone diagnostic imaging software for CT scans. This means it can be safely used in environments where both CT and MRI systems are present, without introducing risks associated with magnetic fields or electromagnetic interference. Always ensure your IT setup meets the software’s technical specifications for optimal performance.
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 | K242624 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K242624 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026