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 K260898
Device Name Transpara (2.1.0)
Applicant
Screenpoint Medical B.V.
Mercator Ii, 7th Floor
Toernooiveld 300
Nijmegen,  NL 6525 EC
Applicant Contact Robin Barwegen
Correspondent
Screenpoint Medical B.V.
Mercator Ii, 7th Floor
Toernooiveld 300
Nijmegen,  NL 6525 EC
Correspondent Contact Robin Barwegen
Classification Product Code
QDQ  
Date Received03/18/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-