CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

System, Image Processing, Radiological

NUCCARDIAC SOFTWARE, INC.

The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cedars-sinai Quantitative Thallium-201 Analysis.

Pre-market Notification Details

Device IDK900697
510k NumberK900697
Device Name:CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
ClassificationSystem, Image Processing, Radiological
Applicant NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda,  CA  92686
ContactVan Train
CorrespondentVan Train
NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda,  CA  92686
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-13
Decision Date1990-05-11

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