đź“‹ FDA Reference
model 3031 cervical spine surface coil
Medical Advances
Summary: The Model 3031 Cervical Spine Surface Coil is a medical imaging device used in MRI to enhance cervical spine imaging. It is primarily used by radiologists and healthcare professionals in diagnostic imaging centers.
FDA Clearance Information
Pathway
510K
Number
K890666 ↗
Decision Date
April 14, 1989
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 3031 Cervical Spine Surface Coil, manufactured by Medical Advances, was cleared via the FDA 510(k) pathway on April 14, 1989. It is classified as a Class II device under product code LNH.
What It Is
The Model 3031 Cervical Spine Surface Coil is an accessory used with MRI machines to improve the quality of images of the cervical spine. It functions by enhancing the signal-to-noise ratio in the targeted area, allowing for clearer and more detailed images. This coil is designed to conform to the anatomy of the cervical spine, providing optimal imaging for diagnostic purposes.
Clinical Applications
This device is commonly used in radiology departments for patients requiring detailed imaging of the cervical spine, such as those with suspected spinal cord injuries, degenerative disc disease, or tumors. It is particularly useful in settings where high-resolution imaging is crucial for diagnosis and treatment planning. The coil is typically used in conjunction with MRI machines in hospitals and specialized imaging centers.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in enhancing MRI images of the cervical spine. It is suitable for patients who need detailed evaluation of spinal pathologies, including tumors, trauma, or degenerative conditions.
Practical Considerations
The Model 3031 Cervical Spine Surface Coil is designed to fit the anatomical contours of the cervical spine, ensuring optimal image quality. It is compatible with most MRI systems, but clinicians should verify compatibility with their specific equipment. Proper positioning and alignment are crucial for obtaining the best imaging results.
Frequently Asked Questions
What is the Model 3031 Cervical Spine Surface Coil used for?
It is used to enhance MRI imaging of the cervical spine, providing clearer and more detailed images for diagnostic purposes.
What specialties typically use this device?
Radiologists and healthcare professionals in diagnostic imaging centers typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in enhancing MRI images of the cervical spine, particularly for patients with spinal pathologies.
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.