Syneris PACS v.1.0.1.0 is a medical imaging software platform that helps radiologists and other clinicians store, view, measure, and report on medical images from multiple imaging systems. It is compliant with DICOM standards and supports secure access and management of images across different healthcare locations.
Intended Use
Syneris PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation.
Technology
Syneris PACS is a software-only, DICOM-compliant Picture Archiving and Communication System (PACS) designed for storage, distribution, visualization, and measurement of radiological images. It features desktop viewer applications, server/cloud storage, multi-monitor support, measurement tools, structured reporting, and supports multi-location access using secure HTTPS communication.
Performance
Syneris PACS underwent software verification and validation testing according to FDA guidance. The testing confirmed that design requirements and intended use were met, and the device performed equivalently to the predicate device in image management workflows.
Predicate Devices
No predicate devices specified
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