Infinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.Infinitt PACS 7.0 is a software system designed to store, process, and display medical images across multiple imaging sources. It allows clinicians to view and manipulate images for diagnosis using advanced tools like 3D visualization, hanging protocols, and secure network features, enhancing access to diagnostic information from anywhere via a web interface.
Intended Use
Infinitt PACS 7.0 is software that receives medical images and data from various imaging sources, stores, communicates, processes, and displays images within or across networks at distributed locations. It supports interpretation of preprocessed DICOM mammographic images for primary diagnosis only on qualified monitors.
Technology
Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM viewer and image management system running on Windows 7/8.1/10. It supports advanced DICOM functions such as JPEG/JPEG2000 compression, DICOM Query/Retrieve, Grayscale Softcopy Presentation State, and user-configurable hanging protocols. It integrates multiple tools including image manipulation, 3D volume rendering, MPR, MIP, mammography CAD interface, and report generation.
Performance
The system underwent comprehensive in-house testing based on predefined functional requirements and user manual instructions, passing all criteria without significant failures. Hazard analysis classified potential risks as moderate with no impact on safety or efficacy identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2017
1 month - 2
FDA Approval
10/27/2017
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