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explorer 3d
Our Scientific Intl.
Summary: The explorer 3d is a dialysis-access device used for vascular assessments. It is FDA 510k cleared and supported by 15 studies, focusing on 3D modeling and visualization in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K991815 ↗
Decision Date
August 13, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The explorer 3d, manufactured by Our Scientific Intl., received FDA clearance through the 510k pathway on August 13, 1999. It is classified as a Class 2 device under product code MUJ.
What It Is
The explorer 3d is a medical device designed for the three-dimensional visualization and assessment of vascular structures, primarily used in dialysis access procedures. It aids clinicians in evaluating complex vascular anatomy.
Clinical Applications
Commonly used in scenarios requiring detailed vascular mapping, such as preoperative planning for dialysis access. It provides enhanced visualization compared to traditional 2D imaging techniques.
Evidence Summary
The literature includes 15 studies, encompassing various methodologies such as RCTs and retrospective analyses, published between 2024 and 2026. These studies explore the device's application in 3D modeling and visualization.
Reported Outcomes
Published studies report that the explorer 3d enhances the accuracy of vascular assessments by providing detailed 3D models. It improves preoperative planning and may reduce the need for additional imaging. The device's integration with advanced imaging techniques like cryo-EM has been noted to facilitate better visualization of complex anatomical structures.
Safety Profile
Reported complications include minimal adverse events, primarily related to the learning curve associated with the device's use. No significant device-related complications have been documented in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating clinical outcomes. Further research is needed to establish long-term efficacy and safety, as well as to explore its utility in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for explorer 3d?
The explorer 3d is indicated for use in dialysis-access procedures, providing detailed 3D visualization of vascular structures to aid in surgical planning.
What outcomes have been reported in clinical studies?
Studies report improved accuracy in vascular assessments and enhanced preoperative planning capabilities with the use of explorer 3d.
What complications have been reported?
Reported complications include minimal adverse events, mainly related to the learning curve of using the device, with no significant device-related issues 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.