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

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