TBS INSIGHT


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

Correspodent Contact christophe lelong
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 06/11/2012
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