K-number	K212523
Device name	VFSS Pro Mobile Digital Imaging System
Applicant	Imagexray, LLC
Product code	OWB
Device class	Class II
Decision date	Nov 5, 2021
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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VFSS Pro Mobile Digital Imaging System

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