📋 FDA Reference
Wimrt Module for Artp Planning System
Prodigm Group
Summary: The wimrt module for the artp planning system is a Class 2 medical device used in dialysis access procedures. It is primarily utilized by nephrologists and interventional radiologists to plan and optimize vascular access for dialysis patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K041971 ↗
Decision Date ?
May 20, 2005
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The wimrt module for artp planning system by Prodigm Group was cleared through the FDA 510(k) pathway on May 20, 2005. It is classified as a Class 2 device under product code MUJ.
What It Is
The wimrt module is a component of the artp planning system designed to aid in the planning of dialysis access procedures. It utilizes advanced imaging and modeling techniques to optimize the placement and function of vascular access devices. This system is particularly useful in ensuring that dialysis access is both effective and sustainable, minimizing complications and improving patient outcomes.
FDA-Cleared Indications
- Planning of dialysis vascular-access procedures, based on the available device record and product code MUJ.
Clinical Applications
- Preprocedural planning for vascular access in patients who require hemodialysis.
- Review and organization of imaging or anatomical information before a dialysis-access procedure.
- Supporting clinical decisions about the planned route and configuration of dialysis vascular access.
Practical Considerations
- The supplied record does not identify specific software versions, hardware requirements, image formats, or supported imaging modalities; users should consult the FDA clearance and manufacturer documentation.
- The module is a planning system component, not an implanted vascular-access device or a treatment device.
- Planning should account for the patient's vascular anatomy, prior access procedures, comorbidities, and current imaging quality.
- Use requires appropriately trained clinicians and should be integrated with the institution's dialysis-access workflow.
- MRI safety labeling cannot be inferred from this record because the device is software and no MRI compatibility statement is provided.
Frequently Asked Questions
What is wimrt module for artp planning system used for?
It is used to plan and optimize vascular access for dialysis patients, ensuring effective and sustainable dialysis treatment.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in dialysis access planning.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access procedures, assisting in optimizing vascular access for dialysis patients.
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.