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lv liberty vision model 1 90yttrium brachytherapy source
Lv Liberty Vision
Summary: The Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source is a medical device used for targeted radiation therapy, specifically in y90-radioembolization procedures. It is primarily utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway
510K
Number
K193602 ↗
Decision Date
May 29, 2020
Product Code
KXK
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 29, 2020. It is manufactured by Lv Liberty Vision and classified as a Class 2 medical device.
What It Is
The Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source is a device that delivers localized radiation therapy using yttrium-90, a radioactive isotope. It is designed for brachytherapy, a form of internal radiation treatment where the source is placed close to or inside the tumor. This approach allows for high doses of radiation to target cancer cells while minimizing exposure to surrounding healthy tissues.
Clinical Applications
This device is commonly used in the treatment of liver cancer through a procedure known as radioembolization. It is particularly useful in cases where tumors are inoperable or when traditional external beam radiation is not feasible. The device is typically used in hospital settings, and the procedure is performed by interventional radiologists in collaboration with oncologists.
Indications for Use
The FDA indications for this device include its use in y90-radioembolization, which is a treatment for certain types of cancer, primarily liver cancer. It is suitable for patients who require targeted radiation therapy to manage tumor growth.
Practical Considerations
The device requires careful handling due to its radioactive nature. It is compatible with standard delivery systems used in brachytherapy procedures. Clinicians should ensure proper sizing and positioning to maximize therapeutic effects while minimizing risks.
Related Literature
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Frequently Asked Questions
What is Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source used for?
It is used for targeted radiation therapy in y90-radioembolization procedures, primarily for treating liver cancer.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in y90-radioembolization, a procedure for delivering targeted radiation therapy to treat certain cancers, especially liver cancer.
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.