Table of Contents
OnePacs Online Documentation
User guides
Accessing the system
Transmitting or uploading cases to OnePacs
Viewing cases
Sharing Cases
Reporting cases
Miscellaneous features
Administrator's guides
Installation guides
Administrative guides
User management
Workflow management
Other administrative features
Transmission computer (Gateway) management
Miscellaneous
Certifications and Registrations
According to US Food and Drug Administration classification rules, the OnePacs system is a 'Medical Image Communication Device', or a class I medical device. OnePacs satisfies the requirements of the FDA for manufacturers of Class I devices, including Establishment Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulation (21 CFR Part 820).
According to the guidelines stated in Directive 93/42/EEC of the European Community, the OnePacs system is a Class I Medical Device. OnePacs satisfies the requirements for bearing the CE mark on its labeling.
We self-certify compliance with:
