RFA-1717DIG, RFA-1717DIC

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


The following data is part of a premarket notification filed by Astel Inc. with the FDA for Rfa-1717dig, Rfa-1717dic.

Pre-market Notification Details

Device IDK212051
510k NumberK212051
Device Name:RFA-1717DIG, RFA-1717DIC
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant ASTEL Inc. 26-79, Gajeongbuk-ro, Yuseong-gu Daejeon,  KR 34113
ContactYonghwan Jeon
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 Received2021-06-30
Decision Date2021-08-25

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