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ge shoulder surface coil cat m1085an
General Electric
Summary: The GE Shoulder Surface Coil is a specialized MRI coil used to enhance imaging of the shoulder region. It is primarily used by radiologists and orthopedic specialists to obtain detailed images for diagnostic purposes.
FDA Clearance Information
Pathway
510K
Number
K892235 ↗
Decision Date
May 11, 1989
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The GE Shoulder Surface Coil was cleared through the FDA 510k pathway on May 11, 1989. Manufactured by General Electric, it is classified as a Class 2 device under product code LNH.
What It Is
The GE Shoulder Surface Coil is an MRI accessory designed to improve the quality of magnetic resonance imaging of the shoulder. It functions by closely fitting around the shoulder, allowing for enhanced signal reception and improved image resolution. This device is particularly useful in capturing detailed images of soft tissues, ligaments, and cartilage in the shoulder area.
Clinical Applications
This coil is commonly used in clinical settings for patients requiring detailed shoulder imaging, such as those with suspected rotator cuff injuries, labral tears, or other shoulder pathologies. It is particularly beneficial in orthopedic and sports medicine practices, as well as in radiology departments. The device is suitable for use in both outpatient imaging centers and hospital settings.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in obtaining high-resolution MRI images of the shoulder. It is particularly useful for patients with shoulder injuries or conditions requiring detailed imaging for diagnosis and treatment planning.
Practical Considerations
The GE Shoulder Surface Coil is designed to fit a range of shoulder sizes, but proper positioning is crucial for optimal image quality. Compatibility with various MRI machines should be verified, and clinicians should be trained in its application to ensure accurate and efficient imaging.
Related Literature
The linked study explored the effects of resistance versus aerobic training on breast cancer patients undergoing neoadjuvant treatment. While the abstract is not available, such studies typically aim to assess the impact of different exercise regimens on treatment outcomes and patient well-being. Limitations may include small sample sizes or lack of detailed imaging data.
Frequently Asked Questions
What is the GE Shoulder Surface Coil used for?
It is used to enhance MRI imaging of the shoulder, providing detailed images for diagnostic purposes.
What specialties typically use this device?
Radiologists, orthopedic specialists, and sports medicine professionals commonly use this device.
What are the FDA-cleared indications?
The device is indicated for obtaining high-resolution MRI images of the shoulder, particularly in cases of injury or pathology.
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.