VICTOREEN PROMOTIONS OF UNAPPROVED RADIATION THERAPY PRODUCTS
This article was originally published in The Gray Sheet
Executive Summary
VICTOREEN PROMOTIONS OF UNAPPROVED RADIATION THERAPY PRODUCTS cited by FDA in a Jan. 10 warning letter to the Cleveland, Ohio- based firm. An attachment to the letter lists 13 devices, including the Radocon V, the Precision Electrometer Model 500 and the Thebes Therapy Beam Analyzer, Model 7000, for which "no 510(k) application" has been cleared.