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decimal astroid dosimetry app
.Decimal
Summary: The Decimal Astroid Dosimetry App is a medical device used for dosimetry in dialysis-access procedures. It is primarily utilized by healthcare professionals in nephrology and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K150547 ↗
Decision Date
May 15, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Decimal Astroid Dosimetry App was cleared via the FDA 510k pathway on May 15, 2015. It is manufactured by .Decimal and classified as a Class 2 device under product code MUJ.
What It Is
The Decimal Astroid Dosimetry App is a specialized software tool designed to assist clinicians in calculating and optimizing dosimetry for dialysis-access procedures. It provides precise measurements and calculations that are crucial for ensuring effective and safe radiation doses during these procedures. The app integrates with existing clinical workflows to enhance accuracy and efficiency.
Clinical Applications
This device is commonly used in clinical settings involving dialysis access, such as nephrology clinics and interventional radiology departments. It aids in the planning and execution of procedures that require precise dosimetry, ensuring optimal patient outcomes. The app is particularly useful for patients undergoing repeated dialysis access interventions, where accurate dosimetry is critical.
Indications for Use
The FDA-cleared indications for the Decimal Astroid Dosimetry App include its use in calculating dosimetry for dialysis-access procedures. This means it is intended for patients who require vascular access for dialysis treatment, ensuring that radiation doses are accurately measured and applied.
Practical Considerations
Clinicians should ensure compatibility with existing systems and verify that the app integrates smoothly with their current workflow. It is important to be familiar with the app's interface and functionalities to maximize its utility in clinical practice. Regular updates and training may be necessary to keep up with software advancements.
Frequently Asked Questions
What is the Decimal Astroid Dosimetry App used for?
It is used for calculating and optimizing dosimetry in dialysis-access procedures.
What specialties typically use this device?
Nephrology and interventional radiology specialties typically use this device.
What are the FDA-cleared indications?
The app is indicated for use in dosimetry calculations for dialysis-access procedures, ensuring accurate radiation dosing.
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.