K-number	K191879
Device name	DRX-Evolution with Carestream Digital Tomosynthesis
Applicant	Carestream Health, Inc.
Product code	KPR
Device class	Class II
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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DRX-Evolution with Carestream Digital Tomosynthesis

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