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 Display, Diagnostic Radiology
510(k) Number K233693
Device Name Nio Color 8MP (MDNC-8132)
Applicant
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Julie Vandecandelaere
Correspondent
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Julie Vandecandelaere
Regulation Number892.2050
Classification Product Code
PGY  
Date Received11/17/2023
Decision Date 12/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-