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 X-Ray, Tomography, Computed, Dental
510(k) Number K161881
Device Name PreXion3D Excelsior
Applicant
PreXion Corporation
Funai Tokyo Technology Center Building,
1-14-1 Kandasuda-cho
Chiyoda-ku,  JP 101-0041
Applicant Contact Shumpeita Torii
Correspondent
PreXion Corporation
Funai Tokyo Technology Center Building,
1-14-1 Kandasuda-cho
Chiyoda-ku,  JP 101-0041
Correspondent Contact Shumpeita Torii
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/08/2016
Decision Date 10/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-