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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 K915542
Device Name QCA PLUS
Applicant
Sanders Data Systems, LLC
3980 Bibbits Dr.
Palo Alto,  CA  94303
Applicant Contact WILLIAM SANDERS
Correspondent
Sanders Data Systems, LLC
3980 Bibbits Dr.
Palo Alto,  CA  94303
Correspondent Contact WILLIAM SANDERS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/1991
Decision Date 01/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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