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medrad hitachi breast imaging surface coil
Medrad
Summary: The Medrad Hitachi Breast Imaging Surface Coil is a specialized MRI coil used for breast imaging. It is primarily utilized by radiologists to enhance image quality in breast MRI scans.
FDA Clearance Information
Pathway
510K
Number
K955626 ↗
Decision Date
February 27, 1996
Product Code
MOS
Device Class
Class 2
Evidence
0 studies
The Medrad Hitachi Breast Imaging Surface Coil was cleared through the FDA 510(k) process on February 27, 1996. Manufactured by Medrad, it is classified as a Class 2 device under product code MOS.
What It Is
The Medrad Hitachi Breast Imaging Surface Coil is a specialized coil designed to be used with MRI systems for breast imaging. It enhances the quality of MRI scans by improving signal-to-noise ratio, allowing for clearer and more detailed images of breast tissue. This device is particularly useful in detecting and diagnosing breast abnormalities, including tumors.
Clinical Applications
This device is commonly used in radiology departments for breast MRI procedures. It is particularly beneficial for patients undergoing screening for breast cancer, as well as those with dense breast tissue where traditional mammography may be less effective. The coil is used by radiologists and technologists in hospital settings and specialized imaging centers.
Indications for Use
The FDA-cleared indications for this device include its use in breast imaging to assist in the detection and diagnosis of breast conditions, such as tumors. It is suitable for patients requiring detailed breast imaging, particularly those with a higher risk of breast cancer.
Practical Considerations
The Medrad Hitachi Breast Imaging Surface Coil is designed to fit a range of MRI systems, but compatibility should be confirmed with specific models. Proper positioning and technique are crucial to optimize image quality, and training may be required for technologists using the coil.
Frequently Asked Questions
What is the Medrad Hitachi Breast Imaging Surface Coil used for?
It is used to improve the quality of MRI scans for breast imaging, aiding in the detection and diagnosis of breast abnormalities.
What specialties typically use this device?
Radiologists and MRI technologists in radiology departments and imaging centers typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in breast imaging to assist in the detection and diagnosis of breast conditions, such as tumors.
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.