INTEGRADWEB PACS SYSTEM

System, Image Processing, Radiological

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Integradweb Pacs System.

Pre-market Notification Details

Device IDK072986
510k NumberK072986
Device Name:INTEGRADWEB PACS SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant GE HEALTHCARE 25 WALNUT STREET Monroe,  CT  06468
ContactJillian M Reed
CorrespondentJillian M Reed
GE HEALTHCARE 25 WALNUT STREET Monroe,  CT  06468
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-23
Decision Date2007-11-20

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