(93 days)
AFFINITY is a software application used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.
The Affinity v1.0 is a Viewer that will be the first Hermes application released on the new development platform Affinity.
The application provides 2D and 3D visualization and processing of medical images in Digital Imaging and Communications in Medicine (DICOM) format from different modalities, such as PET/CT, MR and tomographic reconstructed SPECT from SPECT/CT. Affinity supports coregistration, with the exception of 2D images, and fusion of multiple time points with studies in the same frame of reference, different tracers, and modalities.
Affinity is developed with Microsoft Visual Studio on the .NET framework environment and designed for high throughput clinical scenarios with fast image loading and configurable workflows and layouts. In the design, emphasis has been placed on ease of use, where the user can easily access tools for 3D ROI and uptake analysis. The application supports pre-selection and automatic detection of all uptake areas within the body above a certain threshold level, by using threshold region tool. Where the user can define a threshold for any modality and unit within that modality to include all pixels of the study in a region or islands of regions.
Based on selected regions, quantification of the following parameters can be done SUV, SUVR, SUVbsa, SUVlbm, SUVbw, SUV Peak, SUV Mean, TLG and MTV.
Here's a summary of the acceptance criteria and the study conducted for the Affinity device based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.