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mrcat pelvis
Philips Medical Systems Mr Finland
Summary: The MRCAT Pelvis by Philips Medical Systems is an MR-only imaging solution for radiation therapy planning. It provides synthetic CT images for precise treatment planning, with evidence supporting its accuracy in patient positioning.
FDA Clearance Information
Pathway
510K
Number
K182888 ↗
Decision Date
April 30, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The MRCAT Pelvis was cleared by the FDA via the 510(k) pathway on April 30, 2019. It is manufactured by Philips Medical Systems Mr Finland and is classified as a Class 2 device.
What It Is
The MRCAT Pelvis is a magnetic resonance imaging (MRI) device designed for MR-only radiation therapy planning. It generates synthetic CT images to facilitate accurate dose calculations and patient positioning without the need for CT simulation.
Clinical Applications
Commonly used in radiation therapy for pelvic cancers, the MRCAT Pelvis aids in precise contouring of targets and organs at risk. It is particularly beneficial in scenarios where reducing radiation exposure from CT scans is desired.
Evidence Summary
The literature includes five studies, primarily from 2018 to 2019, encompassing various study designs such as RCTs and feasibility studies. These studies explore the device's accuracy and dosimetric capabilities in radiation therapy planning.
Reported Outcomes
Published studies report that the MRCAT Pelvis provides accurate patient positioning and reliable synthetic CT images for dose calculation in pelvic radiation therapy. The device has demonstrated feasibility in replacing traditional CT simulations, enhancing treatment precision.
Safety Profile
Reported complications include minimal adverse events, with studies primarily focusing on the device's technical performance rather than patient safety outcomes. No significant safety concerns have been highlighted in the available literature.
Evidence Limitations
Current evidence is limited by small sample sizes and a focus on technical feasibility rather than long-term clinical outcomes. Further research is needed to establish comprehensive safety profiles and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for MRCAT Pelvis?
The MRCAT Pelvis is indicated for use in MR-only radiation therapy planning, particularly for pelvic cancers, to enhance treatment precision and reduce reliance on CT imaging.
What outcomes have been reported in clinical studies?
Studies have reported accurate patient positioning and reliable synthetic CT generation for dose calculation, supporting its use in precise radiation therapy planning.
What complications have been reported?
Reported complications include minimal adverse events, with no significant safety concerns highlighted in the studies reviewed.
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.