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mrcat
Philips Medical Systems Mr Finland
Summary: MRCAT is a device by Philips for generating synthetic CT images from MR images, primarily used in radiotherapy planning. Key evidence shows its feasibility and accuracy in image quality and dosimetric agreement.
FDA Clearance Information
Pathway
510K
Number
K151435 ↗
Decision Date
February 25, 2016
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
MRCAT was cleared via the FDA 510(k) pathway on February 25, 2016. It is manufactured by Philips Medical Systems Mr Finland and classified as a Class 2 device.
What It Is
MRCAT is a medical device that generates synthetic CT images from MR images by calculating attenuation. It is intended for use in radiotherapy planning, offering an MR-only workflow for treatment planning.
Clinical Applications
MRCAT is commonly used in clinical scenarios requiring precise radiotherapy planning, such as in the treatment of cervical cancer and brain tumors. It facilitates the integration of MR imaging into radiotherapy workflows.
Evidence Summary
The available literature includes 14 studies, encompassing various study types such as RCTs and prospective studies, published between 2024 and 2025. These studies validate the clinical feasibility and accuracy of MRCAT.
Reported Outcomes
Published studies report that MRCAT provides accurate synthetic CT images with high dosimetric agreement. One study noted a structural similarity index metric (SSIM) improvement of 1.5% and a mean absolute error (MAE) of 18.5 HU, with a gamma pass rate (GPR) of 98.71%.
Safety Profile
Reported complications include no significant adverse events directly attributed to the use of MRCAT. The studies primarily focus on the device's accuracy and feasibility rather than safety concerns.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and short follow-up periods. Further research is needed to assess long-term outcomes and potential safety issues in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for mrcat?
MRCAT is indicated for generating synthetic CT images from MR images, primarily for use in radiotherapy planning.
What outcomes have been reported in clinical studies?
Studies report high accuracy in synthetic CT image generation, with improvements in image quality and dosimetric agreement.
What complications have been reported?
No significant complications have been reported in the studies, with a focus on the device's accuracy and feasibility.
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.