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 1717fcc.

Pre-market Notification Details

Device IDK210985
510k NumberK210985
Device Name:1717FCC
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Rayence Co., Ltd 14, Samsung 1-ro, 1-gil Hwaseong-si,  KR 445-170
ContactKevin Kim
CorrespondentDave Kim
Mtech Group 7505 Fannin St. Ste 610 Houston,  TX  77054
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-01
Decision Date2021-04-28


Device IdentifiersubmissionNumberSupplement
08800018600887 K210985 000

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