EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

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 Evs 4343w / Evs 4343wg / Evs 4343wp / Evs 3643w / Evs 3643wg / Evs 3643wp.

Pre-market Notification Details

Device IDK193017
501k NumberK193017
Device Name:EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
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
ContactShin Dongwook
CorrespondentShin Dongwook
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 Received2019-10-29
Decision Date2019-11-22

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.