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medrad hitachi 1 5t quad c-spine surface coil
Medrad
Summary: The Medrad Hitachi 1.5T Quad C-Spine Surface Coil is a specialized MRI coil used for imaging the cervical spine. It is primarily used by radiologists in hospital and imaging center settings to obtain high-resolution images of the cervical spine.
FDA Clearance Information
Pathway
510K
Number
K954952 ↗
Decision Date
March 13, 1996
Product Code
MOS
Device Class
Class 2
Evidence
0 studies
The Medrad Hitachi 1.5T Quad C-Spine Surface Coil was cleared through the FDA 510(k) pathway on March 13, 1996. It is manufactured by Medrad and classified as a Class 2 device under product code MOS.
What It Is
This device is an MRI surface coil designed specifically for imaging the cervical spine at 1.5 Tesla magnetic field strength. It enhances the quality of images by improving signal-to-noise ratio, which is crucial for detailed visualization of spinal structures. The coil is placed around the patient's neck during MRI scans, allowing for focused imaging of the cervical spine region.
Clinical Applications
The Medrad Hitachi 1.5T Quad C-Spine Surface Coil is commonly used in the diagnosis and evaluation of cervical spine pathologies such as herniated discs, spinal stenosis, and tumors. It is particularly useful in neurology and orthopedic specialties. The device is typically used in hospital radiology departments and specialized imaging centers, catering to adult and pediatric populations requiring detailed cervical spine assessments.
Indications for Use
The FDA indications for this device involve its use in obtaining high-resolution MRI images of the cervical spine. It is intended for patients who require detailed imaging to diagnose conditions affecting the cervical spine, such as degenerative disc disease or spinal cord compression.
Practical Considerations
The coil is designed to fit comfortably around the patient's neck and is compatible with 1.5T MRI systems. Proper positioning of the coil is essential to ensure optimal image quality. Clinicians should be aware of the coil's compatibility with their MRI system and follow manufacturer guidelines for use.
Frequently Asked Questions
What is the Medrad Hitachi 1.5T Quad C-Spine Surface Coil used for?
It is used for obtaining high-resolution MRI images of the cervical spine, aiding in the diagnosis of spinal pathologies.
What specialties typically use this device?
Radiologists, neurologists, and orthopedic specialists commonly use this device in imaging centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in imaging the cervical spine to diagnose conditions such as herniated discs and spinal stenosis.
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.