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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K032762
Device Name XIO RADIATION TREATMENT PLANNING SYSTEM
Applicant
Computerized Medical Systems, Inc.
1145 Corporate Lake Dr.
St. Louis,  MO  63132
Applicant Contact KATHRYN STINSON
Correspondent
Computerized Medical Systems, Inc.
1145 Corporate Lake Dr.
St. Louis,  MO  63132
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received09/05/2003
Decision Date 12/02/2003
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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