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atlas stim headbox nk 31-0601-0077 atlas stim headbox touchproof 31-0601-0089 atlas stim headbox hd 31-0601-0132 ashb fiber optic duplex conn 2m 31-0204-0001 ashb fiber optic duplex conn 7m 31-0204-0002 atlas stim headbox software 36-0301-0006 atlas headbox interface cable nk 31-0204-003 atlas headbox interface cable touchproof 31-0204-004 atlas headbox interface cable hd 31-0204-005 atlas headbox expansion panel 31-0607-0014
Neuralynx
Summary: The Atlas Stim Headbox by Neuralynx is a medical device used for tumor ablation procedures. It is primarily utilized by clinicians in oncology and neurosurgery.
FDA Clearance Information
Pathway
510K
Number
K250094 ↗
Decision Date
April 14, 2025
Product Code
GYC
Device Class
Class 2
Evidence
0 studies
The Atlas Stim Headbox was cleared through the FDA 510k pathway on April 14, 2025. Manufactured by Neuralynx, it is classified as a Class 2 device under product code GYC.
What It Is
The Atlas Stim Headbox is a sophisticated medical device designed for use in tumor ablation procedures. It functions by delivering precise electrical stimulation to targeted areas, aiding in the destruction of tumor cells. The device includes various components such as headboxes, fiber optic connectors, and interface cables, all working together to ensure accurate and effective treatment delivery.
Clinical Applications
This device is commonly used in clinical settings involving tumor ablation, particularly in oncology and neurosurgery. It is suitable for use in hospitals and specialized cancer treatment centers. The device is typically employed in procedures involving patients with brain tumors or other solid tumors where precise ablation is necessary.
Indications for Use
The FDA has cleared the Atlas Stim Headbox for use in procedures involving tumor ablation. This means it is intended for patients who require targeted destruction of tumor cells, particularly in cases where traditional surgical methods may be less effective.
Practical Considerations
The Atlas Stim Headbox is compatible with various headbox models and includes options for different cable lengths and connector types. Clinicians should ensure compatibility with existing equipment and consider the specific needs of each procedure when selecting components.
Frequently Asked Questions
What is the Atlas Stim Headbox used for?
The Atlas Stim Headbox is used for tumor ablation procedures, delivering precise electrical stimulation to destroy tumor cells.
What specialties typically use this device?
This device is typically used by specialists in oncology and neurosurgery.
What are the FDA-cleared indications?
The device is cleared for use in tumor ablation procedures, specifically for targeting and destroying tumor cells.
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.