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, Digital Image Communications, Radiological
510(k) Number K980541
Device Name BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
Applicant
Barco NV Display Systems
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Barco NV Display Systems
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/11/1998
Decision Date 04/09/1998
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
-
-