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Abstract #1856

Retrospective Analysis of Data in RF Heating Tests of Small Passive Medical Implants

Ting Song 1 , Maria Ida Iacono 1 , Leonardo M. Angelone 1 , and Sunder Rajan 1

1 Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States

The purpose of this study is to perform a retrospective analysis of data related to RF-induced heating tests of medical implants provided in U.S. FDA submissions. We report interim data on 55 small passive medical implants for 1.5T and 3.0T. The data show that there is no clear length dependence for devices 120 mm even when the data are stratified by the magnetic field, device type, and test vendor. Most devices less than 50 mm in length showed less than 2.6 oC of temperature change per WB-SAR except for one device that showed 4.5 oC of temperature change per WB-SAR.

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