Registering an x-ray system is not as complicated as it might seem, there are just a few straightforward steps you need to follow. Some states have registration requirements for x-ray systems, and the Food and Drug Administration (FDA) also requires any commercial or medical research to be registered with them before using the machine. This article will outline how you can register your x-ray system.
Register your x-ray system with your state (where applicable)
Each state has different requirements when it comes to what exactly needs to be done when registering an x-ray system. In some states there's no need to register anything. Whereas in other states they have a slightly more complicated process which requires different fees.
To ensure you're compliant with any state registration requirements, you need to check your state requirements. You can do this by looking for radiation on the health department website for your state.
For example, in one state you may have to register the serial numbers of different parts of your x-ray system. The most common part that is registered is the x-ray tube itself. This is why it’s important that you get your x-ray tube before beginning the process of registering with your state.
Register your x-ray system with the FDA
The second thing that you have to do when registering your x-ray system is to register with the FDA who regulate medical devices. The FDA has a form called Form 2579 which is required by your equipment installer or assembler. This means whoever is installing your x-ray equipment is going to be responsible for registering Form 2579 with the FDA.
There are four copies of Form 2579 that have to be used for x-ray machine registration: one copy will go to the FDA, another copy should stay on site, the third copy would go back to whoever installed it, and lastly one would go to the state that requires that information.
In conclusion
Registering your x-ray system is relatively straightforward when you follow the few simple steps we've outlined here. First, find out any applicable registration requirements for your state, which may include registering the serial numbers on parts of your x-ray equipment, then register your x-ray system with the FDA using Form 2579.
Our team of experts are ready and waiting to help ensure everything goes smoothly when completing these steps to correctly register your x-ray equipment, contact us today.
