COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

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 Computed Radiography System With Nx 1.0 Workstation.

Pre-market Notification Details

Device IDK053634
510k NumberK053634
Device Name:COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant AGFA CORPORATION 10 SOUTH ACADEMY ST. Greenville,  SC  29601
ContactJeffery A Jedlicka
CorrespondentJeffery A Jedlicka
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 Received2005-12-29
Decision Date2006-01-17
Summary:summary

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