K-number	K212145
Device name	DR 800 with DSA, DR 800
Applicant	Agfa N.V.
Product code	JAA
Device class	Class II
Decision date	Aug 31, 2021
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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DR 800 with DSA, DR 800

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