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 K223124
Device Name EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Applicant
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor, 29,
Dunchon-Daero 541beon-Gil
Jungwon-Gu, Seongnam-Si,  KR 13216
Applicant Contact Ella An
Correspondent
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor, 29,
Dunchon-Daero 541beon-Gil
Jungwon-Gu, Seongnam-Si,  KR 13216
Correspondent Contact Ella An
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/03/2022
Decision Date 11/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-