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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 K063505
Device Name VISUALASE ENVISION SOFTWARE SYSTEM
Applicant
BIOTEX, INC.
8058 EL RIO ST.
houston,  TX  77054 -4185
Applicant Contact mathew fox
Correspondent
BIOTEX, INC.
8058 EL RIO ST.
houston,  TX  77054 -4185
Correspondent Contact mathew fox
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received11/20/2006
Decision Date 12/12/2006
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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