SAMSUNG RAYPAX SYSTEM

System, Digital Image Communications, Radiological

SAMSUNG SDS CO., LTD

The following data is part of a premarket notification filed by Samsung Sds Co., Ltd with the FDA for Samsung Raypax System.

Pre-market Notification Details

Device IDK991537
510k NumberK991537
Device Name:SAMSUNG RAYPAX SYSTEM
ClassificationSystem, Digital Image Communications, Radiological
Applicant SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey,  TX  76227
ContactHerman Oosterwjick
CorrespondentHerman Oosterwjick
SAMSUNG SDS CO., LTD 2001 EAST OAKSHORES DR. Aubrey,  TX  76227
Product CodeLMD  
CFR Regulation Number892.2020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-03
Decision Date1999-07-06
Summary:summary

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