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module integrated radiotherapy system mirs
Nuclemed
Summary: The Module Integrated Radiotherapy System (MIRS) by Nuclemed is a Class 2 medical device used in radiotherapy procedures. It is primarily utilized by oncologists and radiologists for precise radiation delivery in cancer treatment.
FDA Clearance Information
Pathway
510K
Number
K090182 ↗
Decision Date
May 4, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The MIRS was cleared through the FDA 510k pathway on May 4, 2009, under the product code MUJ. It is manufactured by Nuclemed and classified as a Class 2 device.
What It Is
The Module Integrated Radiotherapy System (MIRS) is a sophisticated device designed to deliver targeted radiotherapy to patients with cancer. It integrates advanced imaging and radiation delivery technologies to enhance precision and efficacy. The system is typically used in hospital settings, allowing clinicians to tailor treatment plans to individual patient needs, minimizing exposure to surrounding healthy tissues.
Clinical Applications
MIRS is commonly used in oncology departments for treating various cancers, including prostate, breast, and head and neck cancers. It is particularly beneficial in scenarios where precise radiation targeting is crucial, such as in tumors located near vital organs. The device is employed by radiation oncologists and medical physicists in both outpatient and inpatient settings, catering to adult and pediatric populations.
Indications for Use
The FDA indications for MIRS involve its use in delivering radiotherapy for patients requiring precise radiation targeting. This includes individuals with localized tumors where minimizing radiation exposure to surrounding healthy tissue is essential.
Practical Considerations
Clinicians should consider the compatibility of MIRS with existing imaging systems for optimal integration. The system requires specific training for operation, and its use may involve coordination with multidisciplinary teams to ensure comprehensive cancer care.
Frequently Asked Questions
What is Module Integrated Radiotherapy System MIRS used for?
It is used for delivering precise radiotherapy in cancer treatment, minimizing radiation exposure to healthy tissues.
What specialties typically use this device?
Radiation oncologists and medical physicists primarily use this device in oncology departments.
What are the FDA-cleared indications?
The device is indicated for delivering targeted radiotherapy to patients with localized tumors, ensuring precision and safety.
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.