đź“‹ FDA Reference
apex detector electronics acquisition interface model xl-4
Transphoton
Summary: The Apex Detector Electronics Acquisition Interface Model XL-4 by Transphoton is used in tumor ablation procedures. It is primarily utilized by oncologists and interventional radiologists to assist in precise tumor targeting.
FDA Clearance Information
Pathway
510K
Number
K033001 ↗
Decision Date
December 24, 2003
Product Code
KPS
Device Class
Class 2
Evidence
0 studies
The Apex Detector Electronics Acquisition Interface Model XL-4 was cleared through the FDA 510(k) pathway on December 24, 2003. Manufactured by Transphoton, it is a Class 2 medical device under product code KPS.
What It Is
The Apex Detector Electronics Acquisition Interface Model XL-4 is an electronic interface device designed to aid in the acquisition of data during tumor ablation procedures. It integrates with ablation systems to enhance precision in targeting and monitoring the ablation process. This device is crucial for ensuring accurate delivery of energy to the tumor site, thereby optimizing treatment outcomes.
Clinical Applications
This device is commonly used in oncology and interventional radiology settings, particularly in hospitals and specialized cancer treatment centers. It is employed during procedures such as radiofrequency ablation, microwave ablation, or cryoablation to treat various types of tumors. The device is suitable for adult and geriatric patient populations undergoing minimally invasive tumor ablation procedures.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures aimed at ablating tumors. It is intended for patients with solid tumors where ablation is deemed an appropriate treatment option, providing enhanced precision and monitoring during the procedure.
Practical Considerations
The Apex Detector Electronics Acquisition Interface Model XL-4 is typically compatible with a range of ablation systems. Clinicians should ensure compatibility with existing equipment and be trained in its operation to maximize its benefits. Proper setup and calibration are essential for optimal performance.
Frequently Asked Questions
What is the Apex Detector Electronics Acquisition Interface Model XL-4 used for?
It is used to assist in the precision targeting and monitoring of tumor ablation procedures.
What specialties typically use this device?
Oncologists and interventional radiologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures to enhance precision and monitoring during treatment.
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.