If a vendor can prove that their product is a Substantial Equivalent to a previously-cleared device, (called a predicate device) then only a Pre Market Notification, or a 510(k) is needed.

For example: After the first mammography system was approved using a PMA, other vendors of these systems could file a SE claim in the form of a 510(k), and would not have to go through the lengthy PMA process which includes these costly clinical trials.


  • Standards


WW stands for Window Width. Window Width controls contrast is a range of grayscale values to be mapped on monitor…


SMPTE (Society for Motion Picture and Television Engineers) is an international standards development organization. SMPTE has specified several test patterns,…

SOP Class

A SOP (Service Object Pair) Class is a combination of a service such as Store, Retrieve, and an object such…