• 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 K170434
Device Name Enterprise Imaging XERO Viewer 8.1
Applicant
Agfa HealthCare N.V.
Septestraat 27
mortsel,  BE b-2640
Applicant Contact jodi coleman
Correspondent
Agfa HealthCare Corporation
10 South Academy Street
greenville,  SC  29601
Correspondent Contact shaeann cavanagh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2017
Decision Date 07/03/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-