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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 K110812
Device Name CT-GUIDE NEEDLE GUIDANCE SYSTEM
Applicant
Activiews, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Activiews, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/23/2011
Decision Date 06/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT01183182
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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