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The OnePacs System is an image management system designed to store and transmit DICOM compliant data between locations such as hospitals, imaging centers, and other health care institutions, and interpretation sites. The OnePacs system archives, distributes, retrieves, and displays such data from all standard DICOM modalities. The OnePacs system allows users to store reports and other information associated with such DICOM compliant data. The OnePacs system may be deployed for educational and research use only, or for clinical use/patient care.
Caution: The OnePacs system as deployed for clinical use is a registered/licensed medical device. Educational and Research versions of the OnePacs system are neither intended nor licensed for clinical use, and should only be used as permitted by applicable and governing regulations. |
Notice for users within the United States:
Caution: The OnePacs system as deployed for clinical use is For Prescription Use Only (US Regulation 21 CFR 801.109). Federal law restricts this device to sale by or on the order of a physician. |
Safety Information
All users of the OnePacs system who will be involved in the treatment or diagnosis of patients should fully read and understand the OnePacs documentation, including these Safety Instructions. Failure to read and follow these instructions and other OnePacs documentation could result in incorrect usage of the software, which could ultimately affect patient outcome.
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Advanced visualizations funtions such as Multi-planar Reconstructions (MPR), Volume Rendering, and other derived images are available in components of the OnePacs system in certain regions such as the United States, Brazil and India.In available regulatory regions. For non-clinical use, or in appropriate regulatory regions, derived images may be created and reviewed within the OnePacs system, such as Multiplanar Reconstructed images (MPR), Volume Rendered images (VR), and other image types. These derived image types involve displaying the source data not in the originally acquired form, but in ways more accessible to human visual interpretation, and may involve rounding errors, volume averaging artifacts, and other sources of error. Such images should be used only as tools accompanying the original source data for interpretation.