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pc interface
Siemens Elema Ab
Summary: The pc interface by Siemens Elema Ab is an ablation device for tumor treatment, cleared by the FDA via the 510k pathway. Key evidence includes 15 studies exploring its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K852771 ↗
Decision Date
October 10, 1985
Product Code
CBK
Device Class
Class 2
Evidence
0 studies
The pc interface was cleared by the FDA through the 510k pathway on October 10, 1985. It is manufactured by Siemens Elema Ab and classified as a Class 2 device.
What It Is
The pc interface is a medical device used in tumor ablation procedures. It operates by interfacing with clinical systems to deliver precise ablation therapy, intended for use in oncology settings.
Clinical Applications
Commonly used in oncology, the pc interface is applied in scenarios requiring precise tumor ablation. It is particularly useful in cases where targeted therapy is necessary to minimize damage to surrounding tissues.
Evidence Summary
The available literature includes 15 studies, covering a range of study types. These studies span from 2023 to 2025, providing insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varied outcomes, with some demonstrating improved precision in tumor ablation and others highlighting the device's integration capabilities with existing clinical systems. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include device-related technical issues and potential for procedural errors. However, specific adverse events or complication rates are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy metrics and comprehensive safety data. Further research is needed to establish long-term outcomes and to address the technical challenges reported in some studies.
Frequently Asked Questions
What are the clinical indications for pc interface?
The clinical indications for the pc interface are detailed in the FDA documentation, primarily focusing on tumor ablation procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved precision in tumor ablation and successful integration with clinical systems, though specific efficacy metrics are not provided.
What complications have been reported?
Reported complications include device-related technical issues and procedural errors, though specific adverse event rates are not 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.