• 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, x-ray, fluoroscopic, image-intensified
510(k) Number K180589
Device Name DR 800 with MUSICA Dynamic
Applicant
Agfa HealthCare N.V.
Septestraat 27
mortsel,  BE b-2640
Applicant Contact wim govaerts
Correspondent
Agfa HealthCare Corporation
10 South Academy Street
greenville,  SC  29601
Correspondent Contact shaeann cavanagh
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/06/2018
Decision Date 04/05/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-