• 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, image processing, radiological
510(k) Number K123528
Device Name SCENIUM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation drive
knoxville,  TN  37932
Original Contact elaine chang
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
KPS  
Date Received11/16/2012
Decision Date 12/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-