K-number	K232305
Device name	AI-Rad Companion Brain MR
Applicant	Siemens Medical Solutions U.S.A.
Product code	QIH
Device class	Class II
Decision date	Oct 23, 2023
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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AI-Rad Companion Brain MR

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