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 System, X-Ray, Stationary
510(k) Number K260227
Device Name EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
Applicant
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Applicant Contact Hanbyul Kim
Correspondent
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Correspondent Contact Hanbyul Kim
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/26/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-