K-number	K223407
Device name	Versana Essential
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code	IYN
Device class	Class II
Decision date	Feb 15, 2023
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Versana Essential

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