DR 600 With Tomosynthesis

System, X-ray, Tomographic

Agfa N.V.

The following data is part of a premarket notification filed by Agfa N.v. with the FDA for Dr 600 With Tomosynthesis.

Pre-market Notification Details

Device IDK193262
510k NumberK193262
Device Name:DR 600 With Tomosynthesis
ClassificationSystem, X-ray, Tomographic
Applicant Agfa N.V. Septestraat 27 Mortsel,  BE B-2640
ContactWim Govaerts
CorrespondentShaeann Cavanagh
Agfa US Corp. 10 South Academy Street Greenville,  SC  29601
Product CodeIZF  
CFR Regulation Number892.1740 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-03-09

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