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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K111299
Device Name AXXENT RADIATION SHIELD - RIGID
Applicant
Xoft, an Icad Company
345 Potrero Ave.
Sunnyvale,  CA  94085
Applicant Contact STEVE LIN
Correspondent
Xoft, an Icad Company
345 Potrero Ave.
Sunnyvale,  CA  94085
Correspondent Contact STEVE LIN
Regulation Number892.5900
Classification Product Code
JAD  
Date Received05/09/2011
Decision Date 07/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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