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prostate probe surface coil catalog bpx-15
Medrad
Summary: The BPX-15 is a surface coil used in prostate imaging, primarily for enhancing MRI scans. It is used by radiologists and urologists to improve diagnostic accuracy in prostate cancer detection.
FDA Clearance Information
Pathway
510K
Number
K901888 ↗
Decision Date
August 10, 1990
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The BPX-15 received FDA clearance through the 510(k) pathway on August 10, 1990. Manufactured by Medrad, it is classified as a Class 2 device under product code LNH.
What It Is
The BPX-15 is a specialized surface coil designed for prostate imaging. It enhances the quality of MRI scans by improving signal-to-noise ratio, allowing for more detailed visualization of the prostate gland. This device is particularly useful in detecting and evaluating prostate cancer, aiding in both diagnosis and treatment planning.
Clinical Applications
This device is commonly used in radiology and urology settings, particularly in hospitals and specialized imaging centers. It is utilized in the evaluation of prostate cancer, often in conjunction with other diagnostic tools like PSA testing and biopsies. The BPX-15 is suitable for adult male patients who require detailed prostate imaging, especially those with suspected or confirmed prostate cancer.
Indications for Use
The BPX-15 is indicated for use in enhancing MRI scans of the prostate. It is primarily used for patients undergoing evaluation for prostate cancer, helping clinicians to better visualize the prostate and any potential tumors.
Practical Considerations
The BPX-15 is compatible with standard MRI machines and is typically used in conjunction with other imaging protocols. Clinicians should ensure proper positioning and calibration to maximize imaging quality. It is important to verify compatibility with the specific MRI system in use.
Frequently Asked Questions
What is the prostate probe surface coil BPX-15 used for?
It is used to enhance MRI imaging of the prostate, improving diagnostic accuracy for conditions like prostate cancer.
What specialties typically use this device?
Radiologists and urologists commonly use this device in the context of prostate cancer diagnosis and management.
What are the FDA-cleared indications?
The device is cleared for use in enhancing MRI scans of the prostate, aiding in the evaluation and diagnosis of prostate conditions.
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.