• 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 system, image processing, radiological
510(k) Number K181939
Device Name icobrain
Applicant
icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Applicant Contact jan verheyden
Correspondent
icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Correspondent Contact jan verheyden
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/19/2018
Decision Date 11/06/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-