IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X

System, Image Processing, Radiological

AGFA CORP.

The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Impax Orthopaedic Workstation, Model Impax Es 5.x.

Pre-market Notification Details

Device IDK050751
510k NumberK050751
Device Name:IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
ClassificationSystem, Image Processing, Radiological
Applicant AGFA CORP. 10 SOUTH ACADEMY ST. Greenville,  SC  29601
ContactPhil Cuscuna
CorrespondentPhil Cuscuna
AGFA CORP. 10 SOUTH ACADEMY ST. Greenville,  SC  29601
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-23
Decision Date2005-04-21
Summary:summary

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