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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 K081076
Device Name VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
Applicant
Velocity Medical Solutions, LLC
1733 Canton Lane
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
Velocity Medical Solutions, LLC
1733 Canton Lane
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/16/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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