Digital Diagnostic Mobile X-ray System

System, X-ray, Mobile

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 Mobile X-ray System.

Pre-market Notification Details

Device IDK181626
510k NumberK181626
Device Name:Digital Diagnostic Mobile X-ray System
ClassificationSystem, X-ray, Mobile
Applicant Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
ContactChang Soeun
CorrespondentChang Soeun
Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si,  KR 16677
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-20
Decision Date2018-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08801643990107 K181626 000
08801643990091 K181626 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.