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ms paed-baby body
Erich Jaeger
Summary: The ms paed-baby body by Erich Jaeger is a medical device cleared by the FDA for clinical use. It is primarily used in prostate artery embolization procedures. Key evidence includes studies on body size judgments and personalized metabolomics.
FDA Clearance Information
Pathway
510K
Number
K023796 ↗
Decision Date
March 3, 2003
Product Code
CCM
Device Class
Class 2
Evidence
0 studies
The ms paed-baby body was cleared by the FDA through the 510(k) pathway on March 3, 2003. It is manufactured by Erich Jaeger and classified as a Class 2 device under product code CCM.
What It Is
The ms paed-baby body is a device used in clinical settings, specifically designed for procedures involving prostate artery embolization. It aids in precise measurements and assessments necessary for such interventions.
Clinical Applications
Commonly used in prostate artery embolization, the ms paed-baby body assists clinicians in accurately targeting and treating prostate-related conditions. It is utilized in both diagnostic and therapeutic contexts.
Evidence Summary
The available literature includes 11 studies, ranging from randomized controlled trials to retrospective analyses. These studies span from 2018 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes, including advancements in cortisol sensing and body size judgment accuracy. These findings highlight the device's role in enhancing diagnostic precision and treatment efficacy in prostate artery embolization.
Safety Profile
Reported complications include potential inaccuracies in body size judgments and challenges in metabolomics profiling. These issues underscore the need for careful application and interpretation of device data.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and the focus on specific clinical applications. Further research is needed to explore broader applications and long-term outcomes associated with the device.
Frequently Asked Questions
What are the clinical indications for ms paed-baby body?
The device is indicated for use in prostate artery embolization procedures.
What outcomes have been reported in clinical studies?
Studies have reported improvements in diagnostic accuracy and treatment efficacy in prostate-related conditions.
What complications have been reported?
Safety data indicate potential inaccuracies in measurements and challenges in data interpretation.
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.