Xeleris 3.1 Processing and Review Workstation

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K130884 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What types of radiological images can the Xeleris 3.1 Workstation process and analyze, and how does it integrate with existing hospital systems?

  The Xeleris 3.1 Workstation is designed for processing, reviewing, and analyzing a wide range of radiological images, including those from X-ray, CT, MRI, and other imaging modalities. It enhances image quality through advanced software-driven tools like reconstruction and analysis. The system integrates with Picture Archiving and Communication Systems (PACS) to streamline workflows, ensuring seamless data transfer and accessibility across radiology departments. This integration helps reduce manual intervention and improves diagnostic efficiency.

• Is the Xeleris 3.1 Workstation reusable or single-use, and what are the maintenance requirements to ensure optimal performance?

  The Xeleris 3.1 Workstation is a reusable, non-sterile device, meaning it is intended for repeated use within a radiology setting. To maintain optimal performance, it requires regular calibration and adherence to manufacturer-provided guidelines for storage and maintenance. Additionally, keeping the software up-to-date through official updates ensures continued functionality and compliance with diagnostic standards.

• What hardware infrastructure is required for the Xeleris 3.1 Workstation to operate effectively in a clinical environment?

  The Xeleris 3.1 Workstation is supplied as a standalone software-hardware system, but it relies on compatible hardware infrastructure to function properly. This includes a dedicated workstation with sufficient processing power, memory, and display capabilities to handle radiological imaging tasks. The system does not specify MRI safety considerations, so it should be placed in areas free from electromagnetic interference that could affect its performance or diagnostic accuracy.

• How was the regulatory pathway for the Xeleris 3.1 Workstation determined, and what does its classification as Class II with Special Controls entail?

  The Xeleris 3.1 Workstation was cleared through the FDA’s 510(k) Traditional pathway, demonstrating substantial equivalence to a predicate device already on the market. Its classification as Class II with Special Controls means it undergoes additional scrutiny beyond standard Class II devices to ensure safety and effectiveness. This includes adherence to specific regulatory requirements related to software validation, image quality, and system performance in radiological diagnostics.