K-number	K190461
Device name	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Applicant	Philips Medical Systems Nederland B.V.
Product code	LNH
Device class	Class II
Decision date	Jun 4, 2019
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

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