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Regulatory News: Article   Printable Version 


Regulatory News Article
510(k) Clearance Granted for FDA Infusion System

Medrada, Inc.’s novel fluorodeoxyglucose (FDG) Intego™ PET Infusion System, an infusion system for positron emission tomography/computed tomography (PET/CT) imaging procedures, has been granted 510(k) clearance by the United States Food and Drug Administration.

The Intego PET Infusion System is an automated system that controls and delivers FDG to the patient. The FDG is extracted from a multi-dose vial and delivered directly to the patient, virtually eliminating manual handling, preparation, and radiation exposure to the technologist. The Intego System has an on-demand dosing system so that the precise dose of FDG can be delivered at any time.

The Intego PET Infusion System is the first infusion system available in the United States that automates the delivery process of FDG.



© 1998-2007 OncoEd.com All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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