K-number	K240980
Device name	EPIQ Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Product code	IYN
Device class	Class II
Decision date	Oct 7, 2024
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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EPIQ Series Diagnostic Ultrasound System

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