CARDIAC SCANNER AND PROCESSING SYSTEM


Device Classification Name

system, tomography, computed, emission

510(k) Number K110507
Device Name CARDIAC SCANNER AND PROCESSING SYSTEM
Applicant
SPECTRUM DYNAMICS (ISRAEL) LTD.
1 ha’rakefet st.
zichron yaacov, 

IL

30900

Applicant Contact ilan sharon
Correspondent
SPECTRUM DYNAMICS (ISRAEL) LTD.
1 ha’rakefet st.
zichron yaacov, 

IL

30900

Correspodent Contact ilan sharon
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 02/22/2011
Decision Date 07/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No