MI View&GO

MI View&GO is a software-only medical imaging application for viewing, manipulating, quantifying, analyzing, and comparing medical images from PET, SPECT, CT, and MR modalities. It is intended for use by trained healthcare professionals to aid in diagnosis and management of oncology, cardiology, neurology, and organ function disorders, and supports radiotherapy treatment planning.

MI View&GO VA40 maintains the same fundamental technological elements as the predicate device: server/client architecture, support for PET/SPECT/CT/MR data, workflow activities for preprocessing and reading, and feature licensing. New features include a General Masking Tool, VQ Ratio and Subtraction Images for Auto Lung 3D, improved Lung Segmentation algorithm, Deauville Score, improved PERCIST Liver algorithm, and enhancements to cardiac layout and user presets.

FDA Recognized Consensus standards include DICOM (PS 3.1–3.20 2023e), IEC 62304 (Medical Device Software Life Cycle Processes), ISO 14971 (Risk Management), IEC 62366-1 (Usability Engineering), and ISO 20417 (Manufacturer Information). Software verification and validation testing per FDA's June 2023 guidance on device software functions was completed.

The device has identical indications for use and fundamental technological characteristics compared to the primary predicate (MI View&GO VA30, K242300). New features do not raise different questions of safety and effectiveness. Performance testing demonstrated improved lung segmentation and PERCIST liver algorithms met acceptance criteria, and risk analysis with implemented controls supports substantial equivalence claims.