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 K093810
FOIA Releasable 510(k) K093810
Device Name BF-NAVI
Applicant
Kgt, Inc.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact RICHARD VINCINS
Correspondent
Kgt, Inc.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact RICHARD VINCINS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/11/2009
Decision Date 06/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-