XGEO GR40CW

Solid State X-ray Imager (flat Panel/digital Imager)

SAMSUNG ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Xgeo Gr40cw.

Pre-market Notification Details

Device IDK140235
510k NumberK140235
Device Name:XGEO GR40CW
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do,  KR 443742
ContactJeongpyo Hong
CorrespondentJeongpyo Hong
SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, Gyeonggi-do,  KR 443742
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-30
Decision Date2014-05-15
Summary:summary

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