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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 K133966
Device Name MODEL-BASED RSA SOFTWARE
Applicant
Halifax Biomedical, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Halifax Biomedical, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/24/2013
Decision Date 03/06/2014
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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