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 K210404
Device Name Transpara 1.7.0
Applicant
ScreenPoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Applicant Contact Umar Waqas
Correspondent
ScreenPoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Correspondent Contact Umar Waqas
Regulation Number892.2090
Classification Product Code
QDQ  
Date Received02/10/2021
Decision Date 06/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-