📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Enhancement of MRI scans of the prostate.
- Use during prostate imaging to improve visualization of the prostate gland and surrounding structures.
Clinical Applications
- Prostate MRI in patients being evaluated for suspected prostate disease.
- Imaging support during radiologic assessment of the prostate.
- Prostate imaging used with other clinical information, such as PSA testing and biopsy findings, when indicated.
Practical Considerations
- The BPX-15 is an MRI surface coil and must be used only with an MRI system and accessories confirmed to be compatible by the facility.
- MRI safety depends on the specific coil, scanner, cables, connectors, and setup; staff should follow the device labeling and the MRI department's screening procedures.
- Correct positioning and calibration are important for image quality and should be performed by trained MRI personnel.
- Patients must undergo routine MRI screening for implants, metallic objects, and other contraindications before scanning.
- The record identifies the device as a Class II device cleared through the 510(k) pathway under product code LNH; the available information does not specify the coil's dimensions or service life.
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.