📋 FDA Reference
Rtdoseplan
Math Resolutions
Summary: The rtdoseplan by Math Resolutions is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to plan and optimize treatment for patients requiring dialysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022961 ↗
Decision Date ?
January 31, 2003
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The rtdoseplan was cleared through the FDA 510(k) pathway on January 31, 2003. It is manufactured by Math Resolutions and classified as a Class 2 device under product code MUJ.
What It Is
The rtdoseplan is a software-based medical device designed to assist clinicians in planning and optimizing treatment for patients undergoing dialysis. It uses mathematical algorithms to calculate and simulate optimal dosing and access strategies, ensuring efficient and effective dialysis treatment. This tool is particularly valuable in complex cases where precise planning is critical.
FDA-Cleared Indications
- Intended for planning dialysis access procedures.
Clinical Applications
- Planning dialysis access procedures for patients who require dialysis.
- Supporting preprocedural planning in patients with complex vascular anatomy.
- Supporting planning for patients with prior dialysis access complications or access failure.
Practical Considerations
- Confirm the exact FDA-cleared labeling and intended use before relying on the software for clinical decisions.
- Verify compatibility with the facility's dialysis equipment, imaging systems, operating systems, and other clinical software.
- Use by trained personnel familiar with dialysis access planning and the software's calculations.
- Software calculations should support, not replace, clinical assessment, vascular imaging, and physician judgment.
- The supplied record does not establish MRI safety, specific hardware requirements, contraindications, supported file formats, or software service life; consult the manufacturer and current labeling.
Frequently Asked Questions
What is rtdoseplan used for?
The rtdoseplan is used for planning and optimizing dialysis access procedures, particularly in patients with complex vascular conditions.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is cleared for planning dialysis access procedures, especially for patients with challenging vascular anatomy or previous access failures.
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.