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Intended Use

Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. It also allows creating digital files for fabrication of physical replicas such as 3D printing from DICOM files. It is intended for use by trained healthcare professionals.

Technology

The device is software that provides image viewing, manipulation (zoom, pan, window/level, etc.), and analysis tools including line measurement, lesion tracking, and cardiology tools. It supports viewing of mammography CAD structured reports and volumetric SUV measurements. It is designed with cybersecurity features per FDA guidance and allows configurable image compression (lossless or lossy).

Performance

Non-clinical testing including software verification, validation, cybersecurity testing, and usability testing were performed. Testing confirmed the device met all acceptance criteria without introducing new safety or effectiveness risks. No clinical testing was performed as part of this submission. Software modifications were verified with regression testing. Cybersecurity testing aligns with FDA guidance issued September 27, 2023.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/31/2025

    2 months
  • 2

    FDA Approval

    4/14/2025

Other devices from Merge Healthcare Incorporated

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