CR 85-X

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

AGFA CORPORATION

The following data is part of a premarket notification filed by Agfa Corporation with the FDA for Cr 85-x.

Pre-market Notification Details

Device IDK062742
510k NumberK062742
Device Name:CR 85-X
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant AGFA CORPORATION 10 SOUTH ACADEMY ST. Greenville,  SC  29601
ContactJudith Harbour
CorrespondentJudith Harbour
AGFA CORPORATION 10 SOUTH ACADEMY ST. Greenville,  SC  29601
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-14
Decision Date2006-10-13
Summary:summary

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