Xeleris 2 Processing and Review Workstation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051673 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 Xeleris 2 Processing and Review Workstation is a computer-based system designed for the display, processing, archiving, and communication of nuclear medicine imaging data. It supports Emission Tomography, planar, and hybrid imaging modalities, including SPECT, PET, and attenuation correction, to enhance diagnostic accuracy.
This workstation processes inputs from Emission Tomography cameras, performing corrections for attenuation and motion, and facilitates anatomical and physiological image analysis. Supplied as a software-enabled system, it is intended for use in radiology settings and has received FDA 510(k) clearance under Special Review (K051673). No third-party review was involved, and the device is classified under product code LLZ.
Frequently asked questions
What types of nuclear medicine imaging data can the Xeleris 2 workstation process and display?
The Xeleris 2 Processing and Review Workstation is designed to handle and process data from Emission Tomography (including SPECT and PET), planar imaging, and hybrid imaging modalities. It also supports attenuation correction and motion correction, which helps improve diagnostic accuracy for these imaging types.
Is the Xeleris 2 workstation intended for use in any specific clinical settings, and how is it supplied?
The Xeleris 2 is intended for use in radiology settings where nuclear medicine imaging is performed. It is supplied as a software-enabled system, meaning it requires installation on a computer-based platform rather than being a standalone hardware device.
How does the Xeleris 2 workstation enhance diagnostic accuracy in nuclear medicine imaging?
The Xeleris 2 performs corrections for attenuation (which accounts for tissue density affecting signal strength) and motion (to reduce blurring from patient movement), enabling more precise anatomical and physiological image analysis. This processing helps clinicians derive clearer and more reliable diagnostic information from SPECT, PET, and hybrid imaging studies.
What regulatory pathway was followed for the FDA clearance of the Xeleris 2, and what does this mean for its use?
The Xeleris 2 received FDA 510(k) clearance under Special Review (K051673), meaning the submission was reviewed by the FDA without third-party involvement. It was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. for its intended use in radiology settings as described.
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: Xeleris V Molecular Imaging | GE HealthCare (United States), Xeleris 2 Processing and Review Workstation, Xeleris 2 Processing & Review Workstation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051673 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems
Sources (1)
- FDA 510(k) K051673 24 fields · synced Oct 6, 2026