K-number	K222360
Device name	AI-Rad Companion (Cardiovascular)
Applicant	Siemens Medical Solutions U.S.A.
Product code	JAK
Device class	Class II
Decision date	Apr 6, 2023
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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AI-Rad Companion (Cardiovascular)

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