21 CFR Subchapter J to IEC Comparison Table for Medical X-Ray Imaging Devices Mammography

Abstract

The requirements or guidelines presented in this document, a NEMA Medical Imaging & Technology Alliance white paper, were considered technically sound at the time they are approved for publication. They are not a substitute for a product seller’s or user’s own judgment with respect to the particular product discussed, and NEMA does not undertake to guarantee the performance of any individual manufacturer’s products by virtue of this document or guide. Thus, NEMA expressly disclaims any responsibility for damages arising from the use, application, or reliance by others on the information contained in these white papers, Standards, or guidelines. The assessment performed in this white paper was completed using the Standards referenced, which may or may not be the most recent versions of 21 CFR Subchapter J or IEC Standards. This whitepaper is part of an ongoing initiative in collaboration with FDA and professional societies and represents our current understanding of how to comply with the FDA guidance “Medical X-Ray Imaging Devices Conformance with IEC Standards” published in May 2019.