DX-D Imaging Package

Solid State X-ray Imager (flat Panel/digital Imager)

Agfa HealthCare N.V.

The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dx-d Imaging Package.

Pre-market Notification Details

Device IDK172784
510k NumberK172784
Device Name:DX-D Imaging Package
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Agfa HealthCare N.V. Septestraat 27 Mortsel,  BE B-2640
ContactWim Govaerts
CorrespondentShaeann Cavanagh
Agfa Healthcare 10 South Academy Street Greenville,  SC  29601
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-15
Decision Date2017-10-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414904233313 K172784 000
05414904233306 K172784 000
05414904233290 K172784 000
05414904233283 K172784 000
05414904252529 K172784 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.