Regulatory Concerns
In the US PACS are classified as Medical Devices, and hence if for sale are regulated by the USFDA. In general they are subject to Class 2 controls and hence require a 510(k), though individual PACS components may be subject to less stringent general controls. Some specific applications, such as the use for primary mammography interpretation, are additionally regulated within the scope of the Mammography Quality Standards Act.
The Society for Imaging Informatics in Medicine (SIIM) is the worldwide professional and trade organization that provides an annual meeting and a peer-reviewed journal to promote research and education about PACS and related digital topics.
Read more about this topic: Picture Archiving And Communication System
Famous quotes containing the word concerns:
“Our ideal ... must be a language as clear as glass—the person looking out of the window knows there is glass there, but he is not concerned with it; what concerns him is what comes through from the other side.”
—Elizabeth Bowen (1899–1973)