• 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, tomography, computed
510(k) Number K112989
Device Name AQUILION CXL
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/06/2011
Decision Date 04/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-