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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 K031779
Device Name CADSTREAM
Applicant
Confirma, Inc.
821 Kirkland Ave.
Kirkland,  WA  98033
Applicant Contact PATRICIA A MILBANK
Correspondent
Confirma, Inc.
821 Kirkland Ave.
Kirkland,  WA  98033
Correspondent Contact PATRICIA A MILBANK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/10/2003
Decision Date 08/06/2003
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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