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 Densitometer, Bone
510(k) Number K121716
Device Name TBS INSIGHT
Applicant
MEDIMAPS GROUP SA
18 CHEMIN DES AULX
PLAN LES OUATES,  CH 1228
Applicant Contact CHRISTOPHE LELONG
Correspondent
MEDIMAPS GROUP SA
18 CHEMIN DES AULX
PLAN LES OUATES,  CH 1228
Correspondent Contact CHRISTOPHE LELONG
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/11/2012
Decision Date 10/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-