IMPAX Agility

System, Image Processing, Radiological

AGFA HEALTHCARE N.V.

The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Impax Agility.

Pre-market Notification Details

Device IDK142316
510k NumberK142316
Device Name:IMPAX Agility
ClassificationSystem, Image Processing, Radiological
Applicant AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel,  BE B 2640
ContactJodi Coleman
CorrespondentShaeann Cavanagh
AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY ST. Greenville,  SC  29601
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-19
Decision Date2015-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414904252437 K142316 000
05414904242902 K142316 000
05414904218525 K142316 000

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