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posterior cervical spine surface coil m1085am
General Electric
Summary: The posterior cervical spine surface coil m1085am by General Electric is a medical imaging device used primarily for high-resolution MRI of the cervical spine. Key evidence highlights its ability to improve signal-to-noise ratio through flexible coil design.
FDA Clearance Information
Pathway
510K
Number
K884369 ↗
Decision Date
November 28, 1988
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on November 28, 1988. It is manufactured by General Electric and classified as a Class 2 device under product code LNH.
What It Is
The posterior cervical spine surface coil m1085am is a specialized MRI coil designed to enhance imaging of the cervical spine by improving the signal-to-noise ratio. It is intended for use in clinical settings to provide detailed images of the cervical spine and surrounding areas.
Clinical Applications
This device is commonly used in clinical scenarios requiring detailed imaging of the cervical spine, such as in cases of spinal trauma, rheumatoid arthritis, and other conditions affecting the cervical region. It is particularly useful in situations where high-resolution imaging is necessary.
Evidence Summary
The available literature includes 9 studies, ranging from case reports to retrospective analyses, published between 1986 and 2023. These studies explore the device's application in various clinical scenarios and its impact on imaging quality.
Reported Outcomes
Published studies report improvements in imaging quality and signal-to-noise ratio when using the posterior cervical spine surface coil. In one case report, the use of MRI with this coil contributed to the resolution of intramedullary hyperintensity. Another study highlighted its utility in assessing rheumatoid arthritis of the cervical spine.
Safety Profile
Reported complications include no significant adverse events directly attributed to the use of the coil. One study noted the absence of underlying pathology in extensive examinations, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design, including case reports and retrospective analyses. Further research is needed to establish standardized protocols and evaluate long-term outcomes.
Frequently Asked Questions
What are the clinical indications for posterior cervical spine surface coil m1085am?
The device is indicated for use in high-resolution MRI of the cervical spine, particularly in cases requiring detailed imaging such as spinal trauma and rheumatoid arthritis.
What outcomes have been reported in clinical studies?
Studies have reported improvements in signal-to-noise ratio and imaging quality, with specific findings including the resolution of intramedullary hyperintensity in certain cases.
What complications have been reported?
Safety data from evidence indicate no significant adverse events directly related to the device, with one study confirming no underlying pathology in extensive examinations.
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.