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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K915644
Device Name CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
Applicant
Nuccardiac Software, Inc.
20503 Yorba Linda Blvd.
Suite 442
Torba Linda,  CA  92686
Applicant Contact VAN TRAIN
Correspondent
Nuccardiac Software, Inc.
20503 Yorba Linda Blvd.
Suite 442
Torba Linda,  CA  92686
Correspondent Contact VAN TRAIN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/17/1991
Decision Date 02/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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