DR 800 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 800 With Tomosynthesis.

Pre-market Notification Details

Device IDK183275
510k NumberK183275
Device Name:DR 800 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-23
Decision Date2019-02-01
Summary:summary

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