3DI INCLUDING CSCORE


Device Classification Name

system, image processing, radiological

510(k) Number K112530
Device Name 3DI INCLUDING CSCORE
Applicant
SHINA SYSTEMS LTD.
6 sireni
haifa, 

IL

32972

Applicant Contact dan laor
Correspondent
SHINA SYSTEMS LTD.
6 sireni
haifa, 

IL

32972

Correspodent Contact dan laor
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/31/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No