K-number	K193283
Device name	AI-Rad Companion Prostate MR
Applicant	Siemens Medical Solutions USA, Inc.
Product code	QIH
Device class	Class II
Decision date	Jul 30, 2020
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 Prostate MR

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