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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K892711
Device Name QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM
Applicant
Quantitative Cardiac Systems (Qcs), Inc.
115 Research Dr.
Ann Arbor,  MI  48103
Applicant Contact J ALLSEBROOK
Correspondent
Quantitative Cardiac Systems (Qcs), Inc.
115 Research Dr.
Ann Arbor,  MI  48103
Correspondent Contact J ALLSEBROOK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/1989
Decision Date 12/14/1989
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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