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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interventional fluoroscopic x-ray system
510(K) Number K121444
Model CSX-20
Device Name FLAT PANEL DETECTOR
Applicant
CANON, INC. - MEDICAL EQUPMENT GROUP
1201 richardson dr, ste 280
richardson,  TX  75080
Contact diane rutherford
Regulation Number892.1650
Classification Product Code
OWB  
Date Received05/15/2012
Decision Date 06/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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