READY VIEW

System, Image Processing, Radiological

GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)

The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems Scs) with the FDA for Ready View.

Pre-market Notification Details

Device IDK110573
510k NumberK110573
Device Name:READY VIEW
ClassificationSystem, Image Processing, Radiological
Applicant GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3200 N GRANDVIEW BLVD, W-827 Waukesha,  WI  53188
ContactElizabeth Mathew
CorrespondentElizabeth Mathew
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3200 N GRANDVIEW BLVD, W-827 Waukesha,  WI  53188
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-01
Decision Date2011-05-03
Summary:summary

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