Identifiers
- 510(k) Number
- K182237 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uMI 550 PET/CT System is a hybrid imaging device combining Positron Emission Tomography (PET) and Computed Tomography (CT) for simultaneous molecular and anatomical imaging. It integrates a digital PET detector with an 80-slice CT scanner, enabling high-resolution diagnostic imaging with improved low-contrast detectability and spatial resolution.
This system is designed for use in radiology departments and is supplied as a reusable medical device. It features an air-cooled design and incorporates AI-driven workflows and total-body data reconstruction for enhanced image quality in oncology, cardiology, and neurology. The device holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD), with regulatory registration numbers including 3015232217 and 9613445.
Frequently asked questions
What clinical specialties is the uMI 550 PET/CT System primarily intended to support in diagnostic imaging?
The uMI 550 PET/CT System is designed to support radiology departments with advanced imaging for oncology, cardiology, and neurology. Its hybrid PET/CT capabilities enable simultaneous molecular and anatomical imaging, improving diagnostic accuracy for conditions in these specialties by combining metabolic activity (PET) with detailed structural imaging (CT).
Is the uMI 550 PET/CT System a single-use or reusable device, and what maintenance features does it include?
The uMI 550 PET/CT System is a reusable medical device, as explicitly stated in the manufacturer’s description. It features an air-cooled design, which helps manage thermal efficiency during prolonged use. While the device is not described as disposable, its reusable nature implies it requires regular maintenance, calibration, and cleaning protocols to ensure optimal performance and sterility between patient scans.
How does the uMI 550 PET/CT System enhance image quality compared to traditional PET/CT systems?
The uMI 550 PET/CT System integrates a digital PET detector with an 80-slice CT scanner, which improves low-contrast detectability and spatial resolution. Additionally, it incorporates AI-driven workflows and total-body data reconstruction, enabling higher-quality imaging for more accurate diagnostics in oncology, cardiology, and neurology. These features help reduce artifacts and enhance diagnostic confidence.
What regulatory pathways has the uMI 550 PET/CT System followed, and what does this mean for potential buyers?
The uMI 550 PET/CT System has obtained FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed predicate device in the U.S. It also complies with the Medical Device Directive (MDD) in Europe, with specific registration numbers listed. For buyers, this means the device meets established regulatory standards for safety and effectiveness in its intended clinical applications, though local compliance requirements (e.g., FDA registration, CE marking) must still be verified for specific markets.
What are the key specifications or features that differentiate the uMI 550 PET/CT System from other PET/CT systems?
The uMI 550 PET/CT System stands out due to its integration of a digital PET detector with an 80-slice CT scanner, which enhances both spatial resolution and low-contrast detectability. Its air-cooled design ensures efficient operation, and the inclusion of AI-driven workflows and total-body data reconstruction optimizes image quality and workflow efficiency. These features collectively improve diagnostic accuracy for complex cases in oncology, cardiology, and neurology.
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: uMI 550: Digital PET/CT | United-Imaging Healthcare, uMI® 550: Digital PET/CT | United-Imaging Healthcare, Molecular Imaging (PET/CT & PET/MR) | United-Imaging
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182237 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K182237 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026