Hybrid Viewer (00859873006189)
Hermes Medical Solutions ABHybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.
Intended Use
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the result to the user. The result can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.
Technology
Hybrid Viewer provides general tools for viewing and processing nuclear medicine and radiology images, including predefined workflows optimized for specific nuclear medicine studies. It features additional DICOM support, motion correction options, quantitative SPECT displays, and clinical workflows for lung shunt assessment, cardiac mediastinum ratio, and kidney uptake assessment. It supports processing of multiple data types including segmentation and RT dose files.
Performance
Performance testing included analytical verification of new clinical workflows against relevant publications and verification testing during development. All new workflows fulfilled acceptance criteria and are safe to use. Comparison to predicate device confirmed no differences in design, operation, and critical performance. Usability testing and validation supported substantial equivalence to the predicate device with no new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/14/2024
5 months - 2
FDA Approval
11/8/2024
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