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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 drive s.w.
calgary, 
Contact carl denis
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/20/2012
Decision Date 04/30/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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