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 K032243
Device Name MINICAT DENTOCAT
Applicant
XORAN TECHNOLOGIES, INC.
309 N. FIRST STREET
ANN ARBOR,  MI  48103
Applicant Contact PREDRAG SUKOVIC
Correspondent
XORAN TECHNOLOGIES, INC.
309 N. FIRST STREET
ANN ARBOR,  MI  48103
Correspondent Contact PREDRAG SUKOVIC
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/22/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-