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510(k) Data Aggregation
(60 days)
LiveMedica Enterprise PACS is a system for distributing, viewing, processing and archiving medical images within and outside healthcare environments. The LiveMedica Enterprise PACS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement.
LiveMedica Enterprise PACS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnosis, however, resides with the doctor and/or their medical staff in their own area of responsibility.
Although the web and technologies allow the software to run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws.
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis.
Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.
LiveMedica Enterprise PACS is a Picture Archiving and Communication System designed to store, retrieve, manage and display DICOM-compliant medical images for diagnostic imaging workflows across hospitals, imaging centers and multi-site healthcare networks. It includes functionality for server-side image rendering, centralized and edge-based study management and routing. The system is to be used by trained healthcare professionals to perform advanced image manipulations, including zoom, pan, window/level adjustments, annotations, measurements and more. LiveMedica Enterprise PACS supports DICOM conformance, HL7/FHIR-based interoperability and integrates with HIS/RIS/EMR systems.
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