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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K040688
Device Name STANDARD IMAGING E.IMRT CALCULATOR
Applicant
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562
Applicant Contact RAYMOND T RIDDLE
Correspondent
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562
Correspondent Contact RAYMOND T RIDDLE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/16/2004
Decision Date 05/11/2004
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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