PROCEDURE REHEARSAL STUDIO(TM)


Device Classification Name

system, image processing, radiological

510(k) Number K112387
Device Name PROCEDURE REHEARSAL STUDIO(TM)
Applicant
SIMBIONIX LTD.
1914 j n pease pl.
charlotte, 
NC 
28262

Applicant Contact shoshana friedman
Correspondent
SIMBIONIX LTD.
1914 j n pease pl.
charlotte, 
NC 
28262

Correspodent Contact shoshana friedman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/18/2011
Decision Date 12/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No