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vista interface system
Vacumetrics
Summary: The Vista Interface System is a medical device used in tumor ablation. It was cleared by the FDA via the 510(k) pathway. Key evidence includes 11 studies, though specific outcomes and safety data are not detailed in the provided abstracts.
FDA Clearance Information
Pathway
510K
Number
K864852 ↗
Decision Date
March 4, 1987
Product Code
BZL
Device Class
Class 2
Evidence
0 studies
The Vista Interface System was cleared by the FDA through the 510(k) pathway on March 4, 1987. It is manufactured by Vacumetrics and classified as a Class 2 device.
What It Is
The Vista Interface System is designed for use in tumor ablation procedures. It operates by delivering energy to target tissues, facilitating the destruction of tumor cells. Its intended use is within clinical settings for the treatment of tumors.
Clinical Applications
Commonly used in oncology, the Vista Interface System is applied in scenarios requiring precise tumor ablation. It is particularly useful in cases where non-invasive or minimally invasive techniques are preferred.
Evidence Summary
The available literature includes 11 studies, covering various aspects of the device's application. These studies range from systematic reviews to case series, with publication dates spanning up to 2024.
Reported Outcomes
Published studies report limited specific outcomes related to the Vista Interface System. The abstracts provided do not detail efficacy findings directly related to this device, indicating a need for more targeted research.
Safety Profile
Reported complications include general safety concerns typical of ablation devices, though specific adverse events related to the Vista Interface System are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the Vista Interface System. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Vista Interface System?
The clinical indications are related to tumor ablation, as noted in FDA documentation.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Vista Interface System are not detailed in the provided evidence.
What complications have been reported?
Safety data specific to the Vista Interface System are not detailed in the provided evidence.
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.