K-number	K230511
Device name	K3900 Ultrasound Imaging System
Applicant	Maui Imaging
Product code	IYO
Device class	Class II
Decision date	Oct 25, 2023
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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K3900 Ultrasound Imaging System

Everything you need for a 510(k) submission. Nothing you don't.