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PubMed

US regulatory considerations for low field magnetic resonance imaging systems.

PMID: 37191776 · 2023

JournalMagma (New York, N.Y.)
Year2023
PMID37191776

Abstract

Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing a wide range of field strengths. Many systems seeking marketing authorization today include new technological features (such as artificial intelligence), but this does not fundamentally change the regulatory paradigm for MR systems. In this review, w

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