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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:

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