đź“‹ FDA Reference
Render-Plan 3-d 4 00 Precise-Plan 1 0
Precision Therapy Intl.
Summary: The render-plan 3-d 4 00 precise-plan 1 0 is a medical device used in dialysis access procedures. It is typically utilized by nephrologists and vascular surgeons to plan and execute precise interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002240 ↗
Decision Date ?
August 23, 2000
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on August 23, 2000, by Precision Therapy Intl. It is classified as a Class 2 device under product code MUJ.
What It Is
The render-plan 3-d 4 00 precise-plan 1 0 is a sophisticated 3D planning tool designed for dialysis access procedures. It enables clinicians to visualize and plan vascular access with high precision, improving outcomes and reducing procedural risks. The device integrates advanced imaging techniques to provide detailed anatomical insights.
FDA-Cleared Indications
- Planning vascular-access procedures for patients who require hemodialysis.
Clinical Applications
- Preprocedural planning for hemodialysis vascular access.
- Mapping vascular anatomy before creation of dialysis access.
- Planning revision procedures for existing dialysis access.
- Supporting clinician assessment of vascular structures before an access intervention.
Practical Considerations
- The available record does not specify device dimensions, configurations, or supported imaging modalities; users should consult the manufacturer’s instructions for use.
- Accurate 3D planning depends on appropriate image quality, registration, and system calibration.
- The record does not establish that the device itself is MRI safe or MRI conditional. MRI compatibility should be confirmed with the manufacturer before use in or near an MRI environment.
- The device is a planning tool and does not replace clinical assessment, vessel evaluation, or the procedural judgment of the treating team.
- The complete FDA indication, contraindications, warnings, and technical specifications should be verified in the official 510(k) documentation and current labeling.
Frequently Asked Questions
What is render-plan 3-d 4 00 precise-plan 1 0 used for?
It is used for planning and executing dialysis access procedures with high precision.
What specialties typically use this device?
Nephrologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access procedures, particularly for patients needing vascular access for hemodialysis.
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.