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 K242683
Device Name QP-Prostate® CAD
Applicant
Quibim S.L.
Avenida De Aragon 30
13 Floor, Office I-J
Valencia,  ES 46021
Applicant Contact Angel Alberich Bayarri
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Classification Product Code
QDQ  
Date Received09/06/2024
Decision Date 03/18/2025
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
-
-