Certifications and Registrations
US FDA: 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.