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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
Applicant
Activiews, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact John j Smith, M.D., J.D.
Correspondent
Activiews, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT01367392
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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