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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 K122888
Device Name CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
Applicant
Cdr Systems, Inc.
#33, 235105 Wrangler Dr. SW
Calgary,  CA TIX OK3
Applicant Contact CARL DENIS
Correspondent
Cdr Systems, Inc.
#33, 235105 Wrangler Dr. SW
Calgary,  CA TIX OK3
Correspondent Contact CARL DENIS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/20/2012
Decision Date 04/30/2013
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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