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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 K090295
Device Name BODYVIZ, MODEL 100
Applicant
Visual Medical Solutions, LLC
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Visual Medical Solutions, LLC
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/05/2009
Decision Date 03/04/2009
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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