MiPACS V5 (1.0.0)
Apryse Software CorpMiPACS V5 is a web-based software system that allows trained healthcare professionals to acquire, view, manipulate, and manage medical and dental images in DICOM format. It is designed to operate within clinical environments to support workflows with integrated image acquisition functionality, enhancing image management but not providing automated diagnosis or clinical decision support.
Intended Use
MiPACS V5 is a software-only medical and dental DICOM image viewing system with integrated image acquisition functionality, intended for use by trained healthcare professionals for acquisition, viewing, manipulation, and management of medical and dental images in DICOM format. It does not provide automated diagnosis or clinical decision support.
Technology
MiPACS V5 is a software-only web-based medical device consisting of a web-based user interface for image viewing and manipulation, an application logic layer managing workflows, an image acquisition interface interoperating with compatible dental devices, a DICOM communication layer supporting DICOM and DICOMweb standards, and a security/access control layer with authentication and encrypted communication.
Performance
Non-clinical testing included software verification and validation consisting of unit, integration, and system-level testing for functional, performance, and security requirements. Bench testing validated image rendering consistency, DICOM conformance, connectivity, database integrity, and clinical workflows including image acquisition, storage, and retrieval. Cybersecurity assessment was conducted through threat modeling and vulnerability analysis.
Predicate Devices
No predicate devices specified
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