Merge Universal Viewer (MUV)

Merge Universal Viewer (MUV) is a software application that provides internet access to multi-modality softcopy medical images, medical data, reports, and patient-related information for diagnostic review, processing, analyzing, reporting, and sharing of DICOM-compliant medical images. It also enables creation of digital files suitable for 3D printing from DICOM inputs, though the resulting physical models are not for diagnostic use. MUV is intended for use by trained healthcare professionals and can be configured for either lossless or lossy compressed image display.

MUV V9.0 adds several new features to the predicate V8.0: ability to display Mammography CAD Structured Reports, volumetric SUV measurement tools, a DICOM Structured Report ingestion panel for lung nodule detection and lesion tracking, cardiology measurement tools for cardiac ultrasound studies, full-resolution mammography display via keyboard shortcut, and cybersecurity improvements. The fundamental software architecture, image viewing capabilities, and DICOM processing technology remain substantially unchanged from the predicate.

Not stated in this summary.

MUV V9.0 and predicate V8.0 share identical intended use for medical image management and processing with the same fundamental scientific technology. All new features added to V9.0 (Mammography CAD SR display, volumetric SUV, lesion tracking, cardiology tools) are already present in reference predicate Image Management V15 (K240822), demonstrating these are not novel functionalities. Comprehensive non-clinical testing—including software verification with regression testing, cybersecurity assessment per FDA September 2023 guidance, usability testing, and design validation—all passed acceptance criteria with no new safety or effectiveness concerns identified, confirming the modifications do not adversely affect device safety or performance.