Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, x-ray, tomography, computed
510(k) Number K120710
Device Name AQUILION PRIME
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
ITX   IYO  
Date Received03/08/2012
Decision Date 04/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-