K-number	K193262
Device name	DR 600 with Tomosynthesis
Applicant	Agfa N.V.
Product code	IZF
Device class	Class II
Decision date	Mar 9, 2020
Decision	Substantially Equivalent
Regulation	892.1740

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Source

View the full FDA submission: accessdata.fda.gov

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DR 600 with Tomosynthesis

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