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 Radiological Computer-Assisted Triage And Notification Software
510(k) Number K252421
Device Name JLK-NCCT
Applicant
JLK, Inc.
Jlk Tower, 5, Teheran-Ro 33-Gil
Gangnam-Gu
Seoul,  KR 06141
Applicant Contact Dongmin Kim
Correspondent
Hogan Lovells
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/01/2025
Decision Date 03/24/2026
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
-
-