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medrad 1 5t pelvic imaging system interface device
Medrad
Summary: The Medrad 1.5T Pelvic Imaging System Interface Device is used to enhance imaging capabilities in pelvic MRI procedures. It is primarily utilized by radiologists and imaging technicians in hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K053042 ↗
Decision Date
November 17, 2005
Product Code
MOS
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 17, 2005, by Medrad. It is classified as a Class 2 device under product code MOS.
What It Is
The Medrad 1.5T Pelvic Imaging System Interface Device is designed to optimize pelvic MRI imaging. It interfaces with MRI systems to improve image quality and diagnostic accuracy. This device is crucial for obtaining detailed images of pelvic structures, aiding in the diagnosis and treatment planning of various conditions.
Clinical Applications
This device is commonly used in radiology departments for pelvic MRI scans, which are essential in diagnosing and monitoring conditions such as tumors, cysts, and other abnormalities in the pelvic region. It is particularly useful in oncology for tumor evaluation and in gynecology for assessing reproductive organs. The device is used in both inpatient and outpatient settings, catering to a diverse patient population.
Indications for Use
The FDA indications suggest that this device is intended for use in enhancing MRI imaging of the pelvic area. It is suitable for patients requiring detailed pelvic imaging, such as those with suspected tumors or other pelvic abnormalities.
Practical Considerations
The device is compatible with 1.5T MRI systems and is typically used in conjunction with standard MRI protocols. Clinicians should ensure proper calibration and positioning to achieve optimal imaging results. It is important to verify compatibility with existing MRI equipment before use.
Frequently Asked Questions
What is the Medrad 1.5T Pelvic Imaging System Interface Device used for?
It is used to enhance the quality of pelvic MRI images, aiding in the diagnosis and evaluation of pelvic conditions.
What specialties typically use this device?
Radiology and oncology specialties commonly use this device, particularly in settings where detailed pelvic imaging is required.
What are the FDA-cleared indications?
The device is indicated for use in improving MRI imaging of the pelvic region, particularly for patients with suspected tumors or other pelvic abnormalities.
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.