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 K240301
Device Name MammoScreen® (3)
Applicant
Therapixel
455 Promenade des Anglais
Nice,  FR 06200
Applicant Contact Quentin De Snoeck
Correspondent
Therapixel
455 Promenade des Anglais
Nice,  FR 06200
Correspondent Contact Quentin De Snoeck
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received02/01/2024
Decision Date 08/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-