uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231482 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uCT ATLAS Astound is a computed tomography (CT) imaging system designed for dual-energy analysis, enabling advanced material differentiation and quantitative assessment in medical imaging. It integrates whole-body scanning capabilities with specialized software to support applications such as bone densitometry, iodine quantification, and virtual non-contrast reconstruction.
This device is intended for use in radiology departments and clinical settings, supplied as a reusable medical imaging system. It requires proper installation, calibration, and maintenance in accordance with manufacturer guidelines, with no indication of single-use or sterile packaging. The system operates within MRI-safe parameters as defined by its specifications and is authorized for commercial distribution in the United States via FDA 510(k) clearance and under the Medical Device Regulation (MDR) in the European Union.
Frequently asked questions
What types of medical imaging applications can this CT system support due to its dual-energy analysis capabilities?
The uCT ATLAS Astound is specifically designed for dual-energy analysis, allowing it to perform advanced imaging tasks such as bone densitometry (measuring bone density), iodine quantification (assessing contrast enhancement), and virtual non-contrast reconstruction (simulating images without contrast agents). These features enable precise material differentiation and quantitative assessments, making it useful for radiology departments and clinical settings where detailed imaging analysis is required.
Is this CT system intended for single-use or reusable applications, and what does that mean for maintenance?
The uCT ATLAS Astound is a reusable medical imaging system, meaning it is built for long-term use in clinical environments. Since it is not single-use, it requires proper installation, regular calibration, and ongoing maintenance as outlined by the manufacturer to ensure accurate and reliable performance. This includes adherence to manufacturer guidelines for upkeep, which may involve periodic servicing or part replacements.
How is this device authorized for commercial distribution, and where is it currently approved?
The uCT ATLAS Astound has been authorized for commercial distribution in the United States through FDA 510(k) clearance (K231482) and is also compliant with the Medical Device Regulation (MDR) in the European Union. These approvals confirm that the device meets regulatory standards for safety and effectiveness in its intended clinical applications, including dual-energy CT imaging.
What safety considerations should be taken into account when installing or using this CT system in a clinical setting?
The uCT ATLAS Astound operates within MRI-safe parameters as defined by its specifications, which means it is compatible with MRI environments when used according to its designated guidelines. However, clinicians and facility staff must follow the manufacturer’s instructions for installation, calibration, and maintenance to ensure proper functionality and safety. Since it is a reusable system, adherence to cleaning and servicing protocols is critical to prevent cross-contamination and maintain imaging accuracy.
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 | K231482 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K231482 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 4, 2026