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510K FDA Inc. successfully cleared FDA review of the AnyScan nuclear medicine system for Mediso Medical Imaging Systems, Ltd. of Budapest, Hungary. 

FDA terminology is exacting when describing medical device Registration, Clearance, and Approval.   It would be inappropriate for a manufacturer to claim FDA "endorsement" for registering their company and its products.   Here are definitions of terms: Registration: Manufacturers and distributors of drugs and devices marketed in the United States must register with the FDA, list their products, and pay a fee. The FDA states, “Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.” Clearance: FDA clearance is an indication...