CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE


Device Classification Name

system, tomography, computed, emission

510(k) Number K112474
Device Name CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
Applicant
CEDARS-SINAI MEDICAL CENTER
8700 beverly blvd
los angeles, 
CA 
90048

Applicant Contact geoff pollard
Correspondent
CEDARS-SINAI MEDICAL CENTER
8700 beverly blvd
los angeles, 
CA 
90048

Correspodent Contact geoff pollard
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 08/26/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No