AI-Rad Companion Prostate MR

AI-Rad Companion Prostate MR is software that processes and annotates MRI images of the prostate in adult males suspected of having prostate cancer. It provides radiologists with viewing, analysis, and evaluation capabilities for multiple MR image types (DCE, ADC, T2, DWI), hosts an external AI plug-in for lesion detection, and allows acceptance, rejection, or editing of the AI-generated results to support diagnostic interpretation and biopsy planning.

The subject device uses an AI-Rad Companion Engine architecture supporting both cloud and edge deployment via web-based interface, whereas the predicate was cloud-only. The automatic segmentation algorithm is now delegated to a separate plug-in device (Prostate MR AI K241770) rather than embedded. The subject offers expanded use scenarios including lesion scoring and PI-RADS computation, plus an automatic workflow option in addition to semi-automatic workflow. Export capabilities now include DICOM Secondary Capture, Structured Report, and GSPS formats.

ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), ISO 15223-1 (symbols), IEC 82304-1 (health software safety), ISO 20417 (manufacturer information), and NEMA DICOM PS 3.1–3.20 (medical imaging communications). Testing also adhered to FDA guidance on device software functions (June 2023) and cybersecurity management (September 2023).

The subject device maintains equivalent intended use and fundamental technology (MR image processing for prostate oncology assessment) as the predicate K193283. Although the segmentation algorithm is now separated into a plug-in and new features (PI-RADS scoring, automatic workflow, additional export formats) have been added, comprehensive verification and validation testing confirmed these enhancements do not adversely affect safety or effectiveness. The core diagnostic workflow and user roles remain unchanged, with improvements only enhancing workflow efficiency and reducing procedural complexity.