📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in MRI-only radiotherapy treatment planning of the brain.
- For generating synthetic CT images used for radiation dose calculation in brain tumor treatment planning.
Clinical Applications
- MRI-only planning for radiotherapy of brain tumors.
- Generation of synthetic CT images from brain MRI data.
- Radiation dose calculation during brain radiotherapy treatment planning.
- Use as part of a clinical workflow that supports planning without a separate CT simulation scan.
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.
Practical Considerations
- The system is intended for brain imaging and radiotherapy planning; it is not a treatment-delivery device.
- The quality of the generated synthetic CT depends on the MRI acquisition, patient positioning, image registration, and the clinical workflow.
- MRI safety requirements apply to the MRI scanner and all associated equipment; the software itself does not determine whether a patient or accessory is safe in the MRI environment.
- Patients with MRI contraindications, such as certain implants or incompatible devices, may not be eligible for the MRI examination needed by the workflow.
- The synthetic CT output should be reviewed and used according to institutional quality-assurance procedures and the applicable radiotherapy planning system requirements.
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.