1717SCV, 1717SGV

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

Rayence Co., Ltd.

The following data is part of a premarket notification filed by Rayence Co., Ltd. with the FDA for 1717scv, 1717sgv.

Pre-market Notification Details

Device IDK201796
510k NumberK201796
Device Name:1717SCV, 1717SGV
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Rayence Co., Ltd. 14, Samsung 1-ro 1-gil Hwaseong-si,  KP
ContactKee Dock Kim
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200, V111 Houston,  TX  77054
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2020-07-23

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