• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K052202
Device Name AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream parkway, e-50
malvern,  PA  19355
Original Contact gary johnson
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received08/12/2005
Decision Date 03/07/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-