MI View&GO
Siemens Medical Solutions USA, Inc.MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.
Intended Use
MI View&GO is a software application for viewing, manipulation, quantification, analysis and comparison of medical images from PET, SPECT, CT, and MR, used by healthcare professionals to manage diseases related to oncology, cardiology, neurology, and organ function, and to aid in radiotherapy planning.
Technology
MI View&GO is a software-only device delivered with Siemens SPECT/CT and PET/CT scanners that provides integrated, advanced image processing capabilities including reviewing, post-processing and basic reading immediately after acquisition. It includes features like Auto Lung 3D, Gaussian filter, segmentation tools, and multi-layout support for enhanced user interface and workflow efficiency.
Performance
Verification and validation activities were performed including software documentation for moderate level of concern. The software meets applicable FDA standards and quality system regulations. Risk management complies with ISO 14971, and cybersecurity controls have been implemented as per FDA guidance to prevent unauthorized access or misuse. Testing showed all functions met predetermined acceptance criteria, ensuring safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/21/2022
29 days - 2
FDA Approval
8/19/2022
Other devices from Siemens Medical Solutions USA, Inc.
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