đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Planning tumor ablation procedures.
Clinical Applications
- Calculating treatment parameters before a tumor ablation procedure.
- Supporting clinical planning for ablation of solid tumors when ablation therapy has been selected.
- Assisting oncology and radiology professionals with treatment-planning calculations.
Practical Considerations
- The available FDA record describes a calculator interface and does not establish compatibility with current ablation generators, probes, imaging systems, or software.
- Use should follow the original labeling, operator instructions, and institutional equipment-compatibility checks.
- The device is a planning aid and does not replace imaging review, clinical judgment, or confirmation of the treatment zone during the procedure.
- The available record does not specify MRI compatibility; do not bring the interface or associated components into an MRI environment unless the manufacturer’s labeling confirms they are safe.
- The record does not provide device dimensions, service life, calibration requirements, or current availability.
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.