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mrcat brain
Philips Medical Systems Mr Finland
Summary: The mrcat brain by Philips Medical Systems is a device used in MRI-only radiotherapy treatment planning for brain tumors. Key evidence highlights its dosimetric accuracy and clinical feasibility.
FDA Clearance Information
Pathway
510K
Number
K193109 ↗
Decision Date
January 24, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The mrcat brain was cleared by the FDA through the 510(k) pathway on January 24, 2020. It is manufactured by Philips Medical Systems Mr Finland and classified as a Class 2 device.
What It Is
The mrcat brain is a synthetic computed tomography (sCT) solution designed for MRI-only radiotherapy treatment planning. It generates sCT images for accurate dose calculation in brain tumor radiotherapy.
Clinical Applications
The device is commonly used in clinical scenarios involving MRI-only radiotherapy for brain tumors, where precise dose calculation is critical for effective treatment planning.
Evidence Summary
The available literature includes five studies, primarily focusing on the clinical validation of the mrcat brain's dosimetric accuracy. These studies range from 2012 to 2025 and include various study types.
Reported Outcomes
Published studies report that the mrcat brain provides accurate synthetic CT images for dose calculation in brain radiotherapy. The device has been validated for its dosimetric accuracy and image quality, supporting its use in clinical settings.
Safety Profile
Reported complications include no significant adverse events directly linked to the use of the mrcat brain. The studies primarily focus on the device's accuracy and feasibility rather than safety concerns.
Evidence Limitations
The evidence is limited by the small number of studies specifically evaluating the mrcat brain. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for mrcat brain?
The mrcat brain is indicated for use in MRI-only radiotherapy treatment planning for brain tumors.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculation and image quality, validating the device's clinical feasibility.
What complications have been reported?
No significant complications have been reported in the studies provided.
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.