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gammacord ii calculator interface
Miles Laboratories
Summary: The Gammacord II Calculator Interface is a medical device used in tumor ablation procedures. It is typically utilized by oncologists and radiologists to assist in precise ablation planning.
FDA Clearance Information
Pathway
510K
Number
K761063 ↗
Decision Date
December 2, 1976
Product Code
JQP
Device Class
Class 1
Evidence
0 studies
The Gammacord II Calculator Interface was cleared through the FDA 510k pathway on December 2, 1976. It is manufactured by Miles Laboratories and classified as a Class 1 device.
What It Is
The Gammacord II Calculator Interface is a device designed to assist in the planning and execution of tumor ablation procedures. It acts as a computational tool that helps clinicians calculate and optimize the parameters needed for effective tumor ablation. This device is particularly useful in ensuring accurate targeting and dosing during the ablation process.
Clinical Applications
This device is commonly used in oncology and radiology settings, particularly in hospitals and specialized cancer treatment centers. It aids in procedures involving the ablation of tumors, such as liver or kidney tumors, where precise calculation of ablation zones is critical. The device is used by healthcare professionals who specialize in interventional radiology and surgical oncology.
Indications for Use
The Gammacord II Calculator Interface is indicated for use in planning tumor ablation procedures. It is suitable for patients with solid tumors that are candidates for ablation therapy, providing clinicians with the necessary calculations to ensure effective treatment.
Practical Considerations
The device is typically compatible with standard ablation equipment and requires minimal setup. Clinicians should be familiar with the interface and ensure it is calibrated correctly before use. It is important to integrate this device into the workflow to optimize treatment planning and execution.
Frequently Asked Questions
What is the Gammacord II Calculator Interface used for?
It is used for planning and optimizing tumor ablation procedures by calculating necessary parameters for effective treatment.
What specialties typically use this device?
Oncologists and radiologists, particularly those specializing in interventional radiology and surgical oncology, typically use this device.
What are the FDA-cleared indications?
The device is cleared for use in planning tumor ablation procedures, assisting in the calculation of ablation parameters for solid tumors.
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.