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 System, Image Processing, Radiological
510(k) Number K093197
Device Name CORONIS FUSION 10MP, MODEL MDCG-10130
Applicant
Barco N.V.
35 President Kennedypark
Kortrijk,  BE B-8500
Applicant Contact LIEVEN DE WANDEL
Correspondent
Barco N.V.
35 President Kennedypark
Kortrijk,  BE B-8500
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/09/2009
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-