• 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 K113421
Device Name MINICAT
Applicant
XORAN TECHNOLOGIES, INC.
5210 South State Road
Ann Arbor,  MI  48108
Applicant Contact MARTHA RUMFORD
Correspondent
XORAN TECHNOLOGIES, INC.
5210 South State Road
Ann Arbor,  MI  48108
Correspondent Contact MARTHA RUMFORD
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/18/2011
Decision Date 07/11/2012
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
-
-