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v i b e video interface biofeedback equ
Nebulae Productions
Summary: The v i b e video interface biofeedback equipment is a Class 2 medical device used primarily for tumor ablation. It has been FDA-cleared since 1980. Current evidence includes five studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K801049 ↗
Decision Date
June 26, 1980
Product Code
HCC
Device Class
Class 2
Evidence
0 studies
The v i b e device, manufactured by Nebulae Productions, received FDA 510k clearance on June 26, 1980. It is classified as a Class 2 device under product code HCC.
What It Is
The v i b e video interface biofeedback equipment is designed for use in tumor ablation procedures. It provides real-time video feedback to assist clinicians in accurately targeting and ablating tumor tissues.
Clinical Applications
Commonly used in oncological settings, the v i b e device aids in the precise ablation of tumors. It is particularly useful in minimally invasive procedures where visual feedback is crucial for effective treatment.
Evidence Summary
The available literature includes five studies registered on ClinicalTrials.gov. These studies vary in type and focus, with no specific outcomes or safety data detailed. The studies span various years, but exact dates are not provided.
Reported Outcomes
Published studies report limited specific outcomes related to the v i b e device. The studies listed do not provide detailed efficacy findings directly linked to the device's use in tumor ablation.
Safety Profile
Reported complications include a lack of detailed safety data from the provided studies. The evidence does not specify adverse events directly associated with the device's use.
Evidence Limitations
The current evidence lacks detailed outcome and safety data specific to the v i b e device. Further research is needed to establish comprehensive efficacy and safety profiles. Study limitations include the absence of direct data linking the device to specific clinical outcomes.
Frequently Asked Questions
What are the clinical indications for v i b e video interface biofeedback equ?
The clinical indications are primarily for tumor ablation procedures, as noted in the FDA documentation.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are limited, with no detailed outcomes directly linked to the device reported.
What complications have been reported?
Safety data from the evidence is sparse, with no specific complications directly associated with the device reported.
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.