• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name system, x-ray, stationary
510(k) Number K112670
Device Name DX-D 600
Original Applicant
AGFA HEALTHCARE N.V.
10 s academy street
greenville,  SC  29601
Original Contact phil cuscuna
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/14/2011
Decision Date 10/27/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-