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smdie device interfacing system
Siemens Medical Solutions Health Services Corporat
Summary: The smdie device interfacing system is an ablation device for tumor treatment, cleared by the FDA via the 510k pathway. Key evidence includes studies on interfacing technologies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K061590 ↗
Decision Date
June 21, 2006
Product Code
MWI
Device Class
Class 2
Evidence
0 studies
The smdie device interfacing system was cleared by the FDA through the 510k pathway on June 21, 2006. It is manufactured by Siemens Medical Solutions Health Services Corporat and classified as a Class 2 device.
What It Is
The smdie device interfacing system is designed for tumor ablation, utilizing advanced interfacing technology to enhance clinical outcomes. It is intended for use in oncology settings to target and ablate tumor tissues.
Clinical Applications
Commonly used in oncology departments, this device aids in the precise ablation of tumors. It is particularly useful in cases where traditional surgical methods are not feasible or pose higher risks.
Evidence Summary
The literature includes 10 studies, primarily from 2020, focusing on interfacing technologies. Study types vary, with some being RCTs and others exploratory in nature. The evidence base is diverse but lacks direct clinical outcome data.
Reported Outcomes
Published studies report advancements in interfacing technologies that could enhance tumor ablation precision. However, specific efficacy outcomes related to tumor size reduction or patient survival are not detailed in the provided studies.
Safety Profile
Reported complications include potential interfacing challenges and device integration issues. However, specific adverse events related to patient safety are not detailed in the available evidence.
Evidence Limitations
The evidence lacks direct clinical outcome data specific to the smdie device interfacing system. Further research is needed to establish efficacy and safety in diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for smdie device interfacing system?
The device is indicated for tumor ablation, particularly in cases where traditional surgical methods are not suitable.
What outcomes have been reported in clinical studies?
Studies highlight advancements in interfacing technologies, but specific clinical outcomes such as tumor reduction are not detailed.
What complications have been reported?
Safety data indicate potential interfacing challenges, though specific patient-related adverse events are not reported.
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.