Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K232753
Device Name EXPD 4343D; EXPD 3643D
Applicant
DRTECH Corporation
Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero
541 Beon-Gil Jungwon-Gu, Seongnam-Si
Seongnam-Si,  KR 13216
Applicant Contact Kim Minjeong
Correspondent
DRTECH Corporation
Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero
541 Beon-Gil Jungwon-Gu, Seongnam-Si
Seongnam-Si,  KR 13216
Correspondent Contact Kim Minjeong
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/08/2023
Decision Date 11/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-