Digital Diagnostic X-ray System (GC80)

System, X-ray, Stationary

SAMSUNG ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Digital Diagnostic X-ray System (gc80).

Pre-market Notification Details

Device IDK143029
510k NumberK143029
Device Name:Digital Diagnostic X-ray System (GC80)
ClassificationSystem, X-ray, Stationary
Applicant SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,  KR 443742
ContactKim Chulsin
CorrespondentKim Chulsin
SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si,  KR 443742
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-21
Decision Date2015-02-04
Summary:summary

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