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Medrad 1 5t Pelvic Imaging System Interface Device
Medrad
Summary: The Medrad 1.5T Pelvic Imaging System Interface Device is used to enhance imaging capabilities in pelvic MRI procedures. It is primarily utilized by radiologists and imaging technicians in hospital and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053042 ↗
Decision Date ?
November 17, 2005
Product Code ?
MOS
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on November 17, 2005, by Medrad. It is classified as a Class 2 device under product code MOS.
What It Is
The Medrad 1.5T Pelvic Imaging System Interface Device is designed to optimize pelvic MRI imaging. It interfaces with MRI systems to improve image quality and diagnostic accuracy. This device is crucial for obtaining detailed images of pelvic structures, aiding in the diagnosis and treatment planning of various conditions.
FDA-Cleared Indications
- Use with compatible 1.5T MRI equipment for pelvic imaging.
- Intended to support MRI visualization of pelvic anatomy during diagnostic examinations.
Clinical Applications
- Pelvic MRI examinations performed with a compatible 1.5T MRI system.
- Imaging of pelvic structures when a radiologist requests MRI evaluation.
- Use in hospital or outpatient imaging departments as part of a pelvic MRI setup.
Practical Considerations
- Use only with MRI systems and accessories confirmed to be compatible by the manufacturer or facility engineering team.
- Follow the device labeling and the MRI system’s conditions for safe use, including field strength and positioning requirements.
- The available record does not specify the device’s physical dimensions, patient-contact materials, or whether it is MR Safe or MR Conditional; verify these details before scanning.
- Inspect, position, and calibrate the interface according to the applicable instructions for use before the examination.
- MRI screening remains necessary for the patient and all equipment brought into the scanner room, including implanted devices, metal objects, and monitoring equipment.
Frequently Asked Questions
What is the Medrad 1.5T Pelvic Imaging System Interface Device used for?
It is used to enhance the quality of pelvic MRI images, aiding in the diagnosis and evaluation of pelvic conditions.
What specialties typically use this device?
Radiology and oncology specialties commonly use this device, particularly in settings where detailed pelvic imaging is required.
What are the FDA-cleared indications?
The device is indicated for use in improving MRI imaging of the pelvic region, particularly for patients with suspected tumors or other pelvic abnormalities.
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.