Accessing the System
Transmitting or Uploading Cases to OnePacs
Other Administrative Features
Transmission Computer (OnePacs Gateway) Management
- OnePacs Gateway User Interface
- Configuring the Gateway for Direct Downloads
- Configuring Compression
- Configuring the Gateway to route studies to more destinations
- Changing the AE Title of the Gateway
- Configuring the Gateway for Multiple Facilities
- Administrative Interface
Interfacing with Other Systems
OnePacs User Forums
Certifications and Registrations
The OnePacs System is 510(k) cleared by the US Food and Drug Administration as a class II medical device. OnePacs satisfies the requirements of the FDA for manufacturers of Class II devices, including Establishment Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulation (21 CFR Part 820), and other regulations.
According to the guidelines stated in Directive 93/42/EEC of the European Community, the OnePacs system distributed in the EU is a Class I Medical Device. OnePacs satisfies the requirements for bearing the CE mark on its labeling.
The OnePacs system is cleared for medical use in Brazil under the ANVISA program.
We self-certify compliance with: