CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE

System, Tomography, Computed, Emission

CEDARS-SINAI MEDICAL CENTER

The following data is part of a premarket notification filed by Cedars-sinai Medical Center with the FDA for Csmc Cardiac Suite- Nuclear Medicine Software.

Pre-market Notification Details

Device IDK112474
510k NumberK112474
Device Name:CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
ClassificationSystem, Tomography, Computed, Emission
Applicant CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BLVD Los Angeles,  CA  90048
ContactGeoff Pollard
CorrespondentGeoff Pollard
CEDARS-SINAI MEDICAL CENTER 8700 BEVERLY BLVD Los Angeles,  CA  90048
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-26
Decision Date2011-09-23

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