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astroid planning app
.Decimal
Summary: The Astroid Planning App by .Decimal is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to plan and optimize dialysis access for patients.
FDA Clearance Information
Pathway
510K
Number
K173940 ↗
Decision Date
May 15, 2018
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Astroid Planning App was cleared through the FDA 510(k) pathway on May 15, 2018. Manufactured by .Decimal, it is classified as a Class 2 device under product code MUJ.
What It Is
The Astroid Planning App is a software tool designed to assist clinicians in planning dialysis access procedures. It provides detailed visualizations and simulations to optimize the placement and function of dialysis access devices. The app aims to improve procedural outcomes by allowing for precise pre-procedural planning.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use it to plan the creation of arteriovenous fistulas or grafts in patients with chronic kidney disease. It helps in selecting the most suitable vascular access site and technique, tailored to individual patient anatomy.
Indications for Use
The FDA-cleared indications for the Astroid Planning App involve its use in planning dialysis access procedures. It is intended for patients who require vascular access for hemodialysis, typically those with end-stage renal disease.
Practical Considerations
The Astroid Planning App is compatible with standard imaging modalities and integrates with existing clinical workflows. It is important to ensure that the app is used in conjunction with up-to-date patient imaging data to maximize accuracy and effectiveness in planning.
Frequently Asked Questions
What is the Astroid Planning App used for?
The Astroid Planning App is used for planning dialysis access procedures, helping clinicians optimize the placement and function of vascular access devices.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access in patients requiring vascular access for hemodialysis, such as those with end-stage renal disease.
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.