EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

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 86p, Expd 86pg, Expd 129p, Expd 129pg.

Pre-market Notification Details

Device IDK223124
510k NumberK223124
Device Name:EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant DRTECH Corporation Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-si,  KR 13216
ContactElla An
CorrespondentElla An
DRTECH Corporation Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-si,  KR 13216
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-03
Decision Date2022-11-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800018407608 K223124 000
08800018407509 K223124 000
08800018407400 K223124 000
08800018407301 K223124 000

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