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emma
Inrange Systems
Summary: emma is a device used in embolization-microspheres and y90-radioembolization. It is FDA-cleared under 510k. Key evidence includes technical validation studies.
FDA Clearance Information
Pathway 510K
Number K150174 ↗
Decision Date February 26, 2015
Product Code NZH
Device Class Class 2
Evidence 0 studies
emma was cleared by the FDA through the 510k pathway on February 26, 2015. It is manufactured by Inrange Systems and classified as a Class 2 device.
What It Is
emma is a medical device designed for use in embolization-microspheres and y90-radioembolization procedures. It assists in delivering therapeutic agents to targeted areas in the body.
Clinical Applications
emma is commonly used in clinical settings for procedures involving embolization and radioembolization, particularly in treating certain types of tumors or vascular abnormalities.
Evidence Summary
The available literature includes 15 studies, with a mix of technical validation and other types of research. The studies range from 2021 to 2025.
Reported Outcomes
Published studies report on the technical validation of the emma device, particularly its accuracy under specific conditions such as hyperbaric environments. However, detailed efficacy outcomes specific to embolization or radioembolization are not extensively covered in the provided evidence.
Safety Profile
Reported complications include potential issues with device accuracy in certain environments, such as hyperbaric conditions. No other specific safety data is detailed in the provided evidence.
Evidence Limitations
The evidence lacks comprehensive clinical trials directly assessing the efficacy and safety of emma in its intended clinical applications. Further research is needed to establish detailed clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for emma?
emma is indicated for use in embolization-microspheres and y90-radioembolization procedures.
What outcomes have been reported in clinical studies?
Technical validation under hyperbaric conditions has been reported, but specific clinical outcomes are not detailed in the provided studies.
What complications have been reported?
Safety data indicates potential accuracy issues in hyperbaric environments, but other complications are not detailed in the evidence.
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.