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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 K120288
Device Name ORTHOCAD SOFTWARE OPTION
Applicant
ESAOTE, S.P.A.
9001 Wesleyan Road
Suite 200
Indianapolis,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
ESAOTE, S.P.A.
9001 Wesleyan Road
Suite 200
Indianapolis,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/31/2012
Decision Date 09/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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