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.
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—Chauncey Wright (1830–1875)