XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION

System, Image Processing, Radiological

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Xeleris 3.1 Processing And Review Workstation.

Pre-market Notification Details

Device IDK130884
510k NumberK130884
Device Name:XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel,  IL 30200
ContactEli Werner
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-03-29
Decision Date2013-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682119306 K130884 000

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