Xcelera
by Philips Medical Systems North America Co.
510(k) K061995
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061995 | Date6 Sep 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Xcelera is a multimodality image and information system (Product Code: LLZ) designed for the import, export, storage, archival, review, analysis, and quantification of medical imaging data. As a software-based solution, it integrates cardiovascular ultrasound and other imaging modalities into a unified platform for clinical workflow management. Its primary function is to enhance diagnostic efficiency by centralizing image and patient information in a structured, accessible format. The system supports comprehensive analysis tools, enabling clinicians to derive quantitative measurements and detailed assessments from imaging studies.
Xcelera is supplied as a software application, intended for use in clinical, diagnostic, or research settings where multimodality imaging data must be managed. It is not described as sterile or single-use; rather, it operates on hospital or enterprise networks, requiring compatible hardware and IT infrastructure for deployment. The device is FDA-cleared under 510(k) K061995, with a decision classification of Substantially Equivalent (SESE) under the Radiology Advisory Committee. No specific MRI safety or sterility classifications are provided, and its regulatory status is limited to the stated 510(k) clearance.
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Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Xcelera imaging system?
The Xcelera is designed to centralize and manage multimodality medical imaging data—including cardiovascular ultrasound and other imaging types—into a single, structured platform. This enhances diagnostic efficiency by providing clinicians with tools for reviewing, analyzing, and quantifying imaging studies in one unified system, streamlining workflows in clinical, diagnostic, or research settings.
How is the Xcelera supplied and deployed?
The Xcelera is supplied as a software application that requires compatible hardware and IT infrastructure for deployment. It operates on hospital or enterprise networks, meaning it is not a standalone device but integrates with existing systems to manage imaging data centrally. No physical hardware is included; the solution relies on network connectivity and server environments for functionality.
Is the Xcelera system sterile or single-use?
The Xcelera is not described as sterile, as it is a software-based solution intended for repeated use in clinical environments. It is designed for long-term deployment on networks, enabling continuous access to imaging data without disposal or reprocessing. Sterility is irrelevant for this type of system, as it does not come into direct contact with patients.
What regulatory clearance does the Xcelera hold?
The Xcelera received FDA clearance under the 510(k) process with the designation K061995, classified as Substantially Equivalent (SESE) under the Radiology Advisory Committee. This clearance confirms its compliance with U.S. regulatory standards for radiology imaging systems, though it does not specify additional classifications like MRI safety or sterility.
Can the Xcelera support imaging modalities beyond cardiovascular ultrasound?
While the Xcelera is primarily associated with cardiovascular ultrasound integration, its multimodality design implies it can also manage other imaging types (e.g., CT, MRI, or X-ray) when paired with compatible hardware and network infrastructure. The system’s strength lies in consolidating diverse imaging data into a cohesive platform for unified analysis and diagnostic workflows.