MI View&GO
Siemens Medical Solutions USA, Inc.MI View&GO by Siemens Medical Solutions USA, Inc. is medical diagnostic software designed to assist healthcare professionals in viewing and analyzing medical images from multiple modalities including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy treatment planning by providing users with tools for image manipulation, quantification, and comparison at or near the scanner console, enhancing workflow efficiency and diagnostic accuracy.
Intended Use
MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time points, supporting functional data such as PET or nuclear medicine, as well as anatomical datasets such as CT or MR. It is utilized by trained healthcare professionals to aid management of diseases in oncology, cardiology, neurology, and organ function, and can also be used to aid in radiotherapy treatment planning.
Technology
MI View&GO is a software-only device integrating molecular imaging handling of PET, SPECT, CT, and MR data directly at the acquisition console using server/client architecture. It supports workflow activities including preprocessing, evaluation and reading, reporting, and storage with software features such as Brain AC-PC alignment, PERCIST, VOI Isocontour, and layout improvements like MIP Rotation. It calculates SUV values and has been modified to enhance device functionality while maintaining the same fundamental technologies as predicate devices.
Performance
The device underwent software verification and validation conforming to FDA guidance for device software functions, demonstrating all software specifications met acceptance criteria and supporting claims of substantial equivalence. No additional performance testing was conducted. Risk analysis and control were completed with testing supporting acceptable safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/2/2024
28 days - 2
FDA Approval
8/30/2024
Other devices from Siemens Medical Solutions USA, Inc.
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