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mrcat head neck
Philips Oy
Summary: The mrcat head neck by Philips Oy is a device used in MR-only radiotherapy planning, specifically for head and neck regions. Key evidence highlights its integration into clinical workflows for improved dose calculation accuracy.
FDA Clearance Information
Pathway
510K
Number
K214081 ↗
Decision Date
April 5, 2022
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The mrcat head neck was cleared via the FDA 510(k) pathway on April 5, 2022. Manufactured by Philips Oy, it is classified as a Class 2 device under product code MUJ.
What It Is
The mrcat head neck is a medical device designed to facilitate MR-only radiotherapy treatment planning. It generates synthetic CT images for accurate dose calculations in head and neck tumor regions.
Clinical Applications
This device is commonly used in radiotherapy planning for patients with head and neck tumors. It is particularly useful in settings where MR imaging is preferred for its superior soft tissue contrast.
Evidence Summary
The available literature includes two studies, one from 2023 and another projected for 2025. These studies encompass various methodologies, including prospective and retrospective analyses.
Reported Outcomes
Published studies report that the mrcat head neck improves the accuracy of dose calculations in MR-only radiotherapy workflows. It has been successfully integrated into clinical settings, enhancing treatment planning for head and neck tumors.
Safety Profile
Reported complications include the need for further validation of synthetic CT algorithms in diverse clinical settings. No significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the need for broader clinical validation. Further research is required to assess long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for mrcat head neck?
The device is indicated for use in MR-only radiotherapy planning for head and neck tumors, facilitating accurate dose calculations.
What outcomes have been reported in clinical studies?
Studies have reported improved dose calculation accuracy and successful integration into clinical workflows for head and neck radiotherapy planning.
What complications have been reported?
Reported complications include the need for further validation of synthetic CT algorithms, with no significant adverse events noted.
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.