CR 10-X DIGITIZER

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 Cr 10-x Digitizer.

Pre-market Notification Details

Device IDK121948
510k NumberK121948
Device Name:CR 10-X DIGITIZER
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel,  BE B 2640
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-07-03
Decision Date2012-07-20
Summary:summary

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