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rfa-300 lda utility
Scanditronix Medical Ab
Summary: The rfa-300 lda utility is a medical device used for tumor ablation, primarily in oncology settings. It is typically utilized by interventional radiologists and oncologists to target and destroy cancerous tissues.
FDA Clearance Information
Pathway
510K
Number
K961400 ↗
Decision Date
January 3, 1997
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The rfa-300 lda utility was cleared through the FDA 510k pathway on January 3, 1997. Manufactured by Scanditronix Medical Ab, it is classified as a Class 2 device under product code IYE.
What It Is
The rfa-300 lda utility is a radiofrequency ablation device designed to deliver controlled thermal energy to tumor tissues. By generating localized heat, it induces coagulative necrosis, effectively destroying cancer cells. This device is particularly useful in minimally invasive procedures, offering a targeted approach to tumor management.
Clinical Applications
Commonly used in oncology, the rfa-300 lda utility is employed in procedures such as liver, kidney, and lung tumor ablations. It is particularly beneficial in cases where surgical resection is not feasible. The device is used in hospital settings, often in interventional radiology suites, and is suitable for adult patients with localized tumors.
Indications for Use
The FDA indications for the rfa-300 lda utility focus on its use in the ablation of solid tumors. It is intended for patients with inoperable or difficult-to-reach tumors, providing a non-surgical option for cancer treatment.
Practical Considerations
The rfa-300 lda utility typically comes with various probe sizes to accommodate different tumor sizes and locations. It is compatible with standard imaging guidance systems, such as ultrasound or CT, to ensure precise targeting. Clinicians should be trained in radiofrequency ablation techniques to optimize outcomes.
Frequently Asked Questions
What is rfa-300 lda utility used for?
The rfa-300 lda utility is used for the ablation of solid tumors, providing a minimally invasive treatment option for cancer patients.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in oncology settings for tumor ablation procedures.
What are the FDA-cleared indications?
The device is cleared for the ablation of solid tumors, offering a treatment option for patients with inoperable or hard-to-reach cancerous tissues.
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.