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 Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K260086
Device Name CadAI-B Dx
Applicant
BeamWorks, Inc.
B1, 107, Chilgokjungang-Daero 136-Gil, Buk-Gu
Daegu,  KR 41404
Applicant Contact Nayeon Oh
Correspondent
BeamWorks, Inc.
B1, 107, Chilgokjungang-Daero 136-Gil, Buk-Gu
Daegu,  KR 41404
Correspondent Contact MinGi Seo
Classification Product Code
QDQ  
Date Received01/12/2026
Decision Date 08/12/2026
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
-
-