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plato brachytheraphy model v 14 0
Nucletron
Summary: The Plato Brachytherapy Model v14.0 by Nucletron is a medical device used in brachytherapy for cancer treatment. It is primarily used by oncologists and radiation therapists to deliver targeted radiation therapy.
FDA Clearance Information
Pathway
510K
Number
K983343 ↗
Decision Date
April 2, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Plato Brachytherapy Model v14.0 was cleared through the FDA 510(k) pathway on April 2, 1999. Manufactured by Nucletron, it is classified as a Class 2 device under product code MUJ.
What It Is
The Plato Brachytherapy Model v14.0 is a specialized device used in brachytherapy, a form of radiation therapy where a radiation source is placed inside or next to the area requiring treatment. This model facilitates precise delivery of radiation, minimizing exposure to surrounding healthy tissues. It is a critical tool in the treatment of various cancers, including prostate, cervical, and breast cancers.
Clinical Applications
This device is commonly used in oncology departments within hospitals and specialized cancer treatment centers. It is particularly useful in treating localized tumors where precision is essential. Oncologists and radiation therapists use this device to plan and execute brachytherapy procedures, often in conjunction with other cancer treatments such as surgery or external beam radiation therapy.
Indications for Use
FDA indications suggest that this device is suitable for patients requiring localized radiation therapy, often for cancers that are accessible via brachytherapy techniques. It is indicated for use in patients with specific types of cancer where targeted radiation can be beneficial.
Practical Considerations
Clinicians should ensure compatibility with existing brachytherapy systems and verify the appropriate sizing for the specific treatment area. Proper training in the use of this device is essential to maximize its therapeutic benefits and minimize potential risks.
Frequently Asked Questions
What is Plato Brachytherapy Model v14.0 used for?
It is used for delivering targeted radiation therapy in the treatment of various cancers, such as prostate and cervical cancer.
What specialties typically use this device?
Oncology and radiation therapy specialties typically use this device for cancer treatment.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring localized radiation therapy for cancer treatment, particularly where brachytherapy is appropriate.
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.