MRCAT Head & Neck
Philips OyMRCAT Head & Neck is a software tool integrated into Philips MR systems that automatically processes MRI data to create synthetic CT-like images for radiation therapy treatment planning in patients with soft tissue tumors in the head and neck region. It helps clinicians accurately estimate radiation dose distributions without needing a separate CT scan, improving planning precision and patient care.
Intended Use
MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.
Technology
MRCAT Head & Neck is a software plug-in for Philips Ingenia MR-RT systems that uses MRI mDixon sequences and applies a convolutional neural network (CNN) to segment tissue types and assign Hounsfield Unit (HU) values, producing CT-like images for radiotherapy planning.
Performance
Performance testing included non-clinical verification and validation demonstrating compliance with FDA-recognized standards and equivalence to predicate MRCAT Brain device; clinical testing shows dose calculation accuracy within 5% compared to CT, with spatial accuracy suitable for treatment planning.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/27/2021
3 months - 2
FDA Approval
4/5/2022
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