K-number	K213620
Device name	ATUSA Automated 3D Breast Ultrasound System
Applicant	Isono Health, Inc.
Product code	IYO
Device class	Class II
Decision date	Apr 22, 2022
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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ATUSA Automated 3D Breast Ultrasound System

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ATUSA Automated 3D Breast Ultrasound System