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Monaco
Impac Medical Systems
Summary: Monaco is a dialysis-access device by Impac Medical Systems, cleared by the FDA. It is primarily used in dialysis procedures, with studies focusing on its dosimetry evaluation and MLC transmission optimization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K132971 ↗
Decision Date ?
November 20, 2013
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Monaco received FDA clearance through the 510(k) pathway on November 20, 2013. It is manufactured by Impac Medical Systems and classified as a Class 2 device.
What It Is
Monaco is a medical device designed for use in dialysis procedures. It is intended to facilitate access for dialysis treatment, ensuring efficient and safe patient care.
FDA-Cleared Indications
Summary
Clinical Applications
Monaco is commonly used in clinical settings for patients requiring dialysis. It is particularly useful in scenarios where precise dosimetry and treatment planning are critical.
Evidence Summary
The available literature includes 15 studies, with a mix of study types such as RCTs and retrospective analyses, spanning from 2018 to 2025.
Reported Outcomes
Published studies report that Monaco effectively aids in dialysis treatment planning, with specific focus on dosimetry evaluation and MLC transmission optimization. However, detailed efficacy outcomes are limited in the provided evidence.
Safety Profile
Reported complications include potential delineation errors during replication and expansion operations, which may affect dosimetry evaluation. No other specific adverse events are detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of detailed efficacy outcomes and specific safety data. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The supplied FDA indication is only "Summary," so the specific intended use, device configuration, and patient population cannot be confirmed from this record.
- Do not assume that Monaco is a dialysis-access device based only on the existing page text; the record does not provide supporting labeling for that claim.
- Size, compatibility, MRI status, contraindications, handling instructions, and service life should be verified in the manufacturer’s current labeling.
- Clinical use should follow the FDA-cleared labeling and institutional procedures.
Frequently Asked Questions
What are the clinical indications for Monaco?
Monaco is indicated for use in dialysis-access procedures, facilitating treatment planning and dosimetry evaluation.
What outcomes have been reported in clinical studies?
Studies have focused on dosimetry evaluation and MLC transmission optimization, but detailed efficacy outcomes are limited.
What complications have been reported?
Safety data indicates potential delineation errors affecting dosimetry, with no other specific complications detailed.
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.