The Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices.

A PACS system is a medical device and requires the vendor to submit a premarket approval (PMA) or a  510(k) to the FDA, based upon the device classification and whether the product has a predicate device.  In addition, the support of a quality system and registration with the FDA of the product and facility is required.

PACS systems and devices such as digitizers, viewers that apply image processing, and other devices that basically process the image data are identified as Class II devices and require a 510(k).

The FDA home page is http://www.fda.gov/.

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