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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Quality-Assurance, Radiologic
510(k) Number K042733
Device Name STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
Applicant
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562 -2766
Applicant Contact RAYMOND RIDDLE
Correspondent
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562 -2766
Correspondent Contact RAYMOND RIDDLE
Regulation Number892.1940
Classification Product Code
LHO  
Subsequent Product Codes
IXG   IYE   LLZ   LMB   LMD  
Date Received10/01/2004
Decision Date 11/15/2004
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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