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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K101697
Device Name ENSITE VERISMO SEGMENTATION TOOL V.2.0
Applicant
St Jude Medical
177 E. County Rd. B
St.Paul,  MN  55117
Applicant Contact KRIS MILLER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/16/2010
Decision Date 09/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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