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philips comprehensive cardiac analysis cca - plaque assessment tool
Philips Medical Systems (Cleveland)
Summary: The Philips Comprehensive Cardiac Analysis CCA is a plaque assessment tool used in cardiology to evaluate cardiac health, particularly in assessing plaque in coronary arteries. It is primarily used by cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K092747 ↗
Decision Date
October 9, 2009
Product Code
JAK
Device Class
Class 2
Evidence
419 studies
The Philips Comprehensive Cardiac Analysis CCA was cleared via the FDA 510k pathway on October 9, 2009. It is manufactured by Philips Medical Systems and is classified as a Class 2 device under the product code JAK.
What It Is
The Philips Comprehensive Cardiac Analysis CCA is a medical imaging tool designed to assess plaque in coronary arteries. It utilizes advanced imaging techniques to provide detailed analysis of cardiac structures, aiding in the diagnosis and management of cardiovascular diseases. This device is particularly useful in identifying and quantifying plaque buildup, which is crucial for assessing the risk of coronary artery disease.
Clinical Applications
This device is commonly used in cardiology and radiology settings to evaluate patients with suspected or known coronary artery disease. It is particularly valuable in pre-operative assessments and routine cardiac evaluations. The tool is used in hospitals and specialized cardiac centers, primarily serving adult patients who are at risk for or have a history of cardiovascular conditions.
Indications for Use
The device is indicated for assessing plaque in coronary arteries, which is essential for diagnosing and managing coronary artery disease. It helps in evaluating the risk of heart attacks and other cardiovascular events by providing detailed images of plaque deposits.
Practical Considerations
The device is compatible with standard imaging systems used in cardiology. Clinicians should be familiar with interpreting advanced cardiac imaging results. Proper training in the use of this tool is recommended to ensure accurate assessments.
Related Literature
The linked study investigates the future cardiovascular disease risk in patients with Phenylketonuria (PKU) who are on a low phenylalanine diet. Although the abstract is not available, the study likely explores how dietary management in PKU patients impacts their long-term cardiovascular health. Limitations include the lack of available data and specifics on study design and outcomes.
Linked Studies (20)
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Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips Comprehensive Cardiac Analysis CCA used for?
It is used for assessing plaque in coronary arteries to evaluate the risk of coronary artery disease.
What specialties typically use this device?
Cardiologists and radiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is cleared for assessing plaque in coronary arteries to aid in the diagnosis and management of coronary artery 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.