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oneview interface
Nxstage Medical
Summary: The Oneview Interface by Nxstage Medical is a clinician-facing device used in tumor ablation. Cleared by the FDA via the 510k pathway, it is supported by two studies focusing on user interface design and data visualization.
FDA Clearance Information
Pathway
510K
Number
K040074 ↗
Decision Date
April 8, 2004
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Oneview Interface was cleared by the FDA on April 8, 2004, under the 510k pathway. It is manufactured by Nxstage Medical and classified as a Class 2 device.
What It Is
The Oneview Interface is a device designed for use in tumor ablation procedures. It facilitates the clinician's interaction with complex data sets, enhancing the visualization and management of clinical information.
Clinical Applications
Commonly used in scenarios requiring precise tumor ablation, the Oneview Interface aids clinicians in visualizing and interpreting complex data, thereby improving decision-making in treatment planning.
Evidence Summary
The literature includes two studies, one from 2018 and another from 2013, focusing on user interface design and data visualization methodologies. These studies are categorized as 'other' types.
Reported Outcomes
Published studies report advancements in user interface design that enhance the independence and quality of life for seniors, as well as improved data visualization techniques for RNAi screening. However, specific clinical efficacy outcomes related to tumor ablation are not detailed.
Safety Profile
Reported complications include potential challenges in user interface adaptability and the need for further refinement in data visualization tools. No direct adverse events related to clinical use are documented.
Evidence Limitations
The evidence is limited by the lack of direct clinical outcome data related to tumor ablation. Further research is needed to establish the device's efficacy and safety in practical clinical settings.
Frequently Asked Questions
What are the clinical indications for Oneview Interface?
The Oneview Interface is indicated for use in tumor ablation procedures, aiding in data visualization and decision-making.
What outcomes have been reported in clinical studies?
Studies report improvements in user interface design and data visualization, but specific clinical outcomes for tumor ablation are not detailed.
What complications have been reported?
Reported complications include challenges with user interface adaptability and data visualization, with no direct adverse clinical events documented.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.