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 Fracture
510(k) Number K240712
Device Name icobrain aria
Applicant
Icometrix Nv
Kolonel Begaultlaan 1b/12
Leuven,  BE 3012
Applicant Contact Dirk Smeets
Correspondent
Icometrix Nv
Kolonel Begaultlaan 1b/12
Leuven,  BE 3012
Correspondent Contact Dirk Smeets
Classification Product Code
QBS  
Date Received03/15/2024
Decision Date 11/07/2024
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
-
-