MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM


Device Classification Name

system, tomography, computed, emission

510(k) Number K072468
Device Name MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
Applicant
SPECTRUM DYNAMICS LTD.
20 hata’as st.
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
SPECTRUM DYNAMICS LTD.
20 hata’as st.
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 09/04/2007
Decision Date 10/01/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls