EXPD 4343P, EXPD 3643P

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

DRTECH Corporation

The following data is part of a premarket notification filed by Drtech Corporation with the FDA for Expd 4343p, Expd 3643p.

Pre-market Notification Details

Device IDK193031
501k NumberK193031
Device Name:EXPD 4343P, EXPD 3643P
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si,  KR 13216
ContactDongwook Shin
CorrespondentDongwook Shin
DRTECH Corporation Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero541 Beon-gil, Jungwon-gu, Seongam-si,  KR 13216
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-30
Decision Date2019-11-22

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