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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K120300
Device Name CT-GUIDE NEEDLE GUIDANCE SYSTEM
Original Applicant
ACTIVIEWS LTD
555 thirteenth street, nw
washington,  DC  20004
Original Contact john j smith, m.d., j.d.
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/31/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Clinical Trials NCT01367392
Reviewed by Third Party No
Expedited Review No
Combination Product No
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