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vascular sono
Pajunk Gmbh Medizintechnologie
Summary: The vascular sono by Pajunk Gmbh Medizintechnologie is a medical device used for vascular imaging. It is FDA 510k cleared and has been evaluated in 15 studies, focusing on its application in embolization-coils.
FDA Clearance Information
Pathway
510K
Number
K113196 ↗
Decision Date
February 6, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The vascular sono was cleared by the FDA through the 510k pathway on February 6, 2012. It is manufactured by Pajunk Gmbh Medizintechnologie and classified as a Class 2 device under product code DYB.
What It Is
The vascular sono is an ultrasound device designed for vascular imaging, aiding in the visualization and assessment of blood vessels. It is primarily used in procedures involving embolization-coils.
Clinical Applications
Commonly used in interventional radiology, the vascular sono assists in the precise placement of embolization-coils and other vascular interventions. It provides real-time imaging to guide clinical decisions.
Evidence Summary
The literature includes 15 studies, with various types such as RCTs and case series, published between 2024 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the vascular sono is effective in enhancing the precision of vascular interventions, particularly in embolization procedures. The device's real-time imaging capabilities improve procedural outcomes.
Safety Profile
Reported complications include minor adverse events related to ultrasound exposure, but no significant safety concerns have been identified in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to establish long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for vascular sono?
The vascular sono is indicated for use in vascular imaging, particularly in procedures involving embolization-coils.
What outcomes have been reported in clinical studies?
Studies have reported improved precision in vascular interventions and enhanced procedural outcomes with the use of the vascular sono.
What complications have been reported?
Reported complications include minor adverse events related to ultrasound exposure, with no significant safety concerns noted.
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.