Name: Predicase
Price: 199 USD

K-number	K191777
Device name	Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Applicant	Ge Medical Systems, LLC
Product code	JAK
Device class	Class II
Decision date	Jul 26, 2019
Decision	Substantially Equivalent
Regulation	892.1750

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

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