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render-plan 3-d
Precision Therapy Intl.
Summary: The render-plan 3-d is a clinician-facing device used for 3-D ultrasound imaging, primarily in dialysis-access procedures. Key evidence highlights its efficacy in improving diagnostic accuracy over traditional 2-D imaging.
FDA Clearance Information
Pathway
510K
Number
K992864 ↗
Decision Date
September 9, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The render-plan 3-d was cleared by the FDA through the 510(k) pathway on September 9, 1999. It is manufactured by Precision Therapy Intl. and classified as a Class 2 device under product code MUJ.
What It Is
The render-plan 3-d is a medical device designed for 3-D ultrasound imaging, enhancing visualization of anatomical structures. It is intended for use in clinical settings to improve diagnostic accuracy and guide surgical interventions.
Clinical Applications
Commonly used in dialysis-access procedures, the render-plan 3-d provides detailed 3-D imaging to assist clinicians in evaluating vascular structures and planning interventions. It is also utilized in educational settings to improve ultrasound interpretation skills.
Evidence Summary
The available literature includes 13 studies, comprising prospective and retrospective analyses, systematic reviews, and case series, published between 2021 and 2022. These studies explore the device's application in various clinical scenarios.
Reported Outcomes
Published studies report that the render-plan 3-d improves diagnostic accuracy and sensitivity in detecting anatomical irregularities compared to 2-D ultrasound. It has been shown to enhance visualization in thyroid cancer diagnosis and other applications.
Safety Profile
Reported complications include minor technical challenges related to device operation and image interpretation. No significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more randomized controlled trials to establish long-term efficacy and safety. Further research is needed to explore its application in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for render-plan 3-d?
The render-plan 3-d is indicated for use in dialysis-access procedures and other clinical scenarios requiring enhanced 3-D imaging.
What outcomes have been reported in clinical studies?
Studies have reported improved diagnostic accuracy and sensitivity in detecting anatomical irregularities compared to traditional 2-D ultrasound.
What complications have been reported?
Reported complications include minor technical challenges, with no significant adverse 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.