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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
Predetermined Change
Control Plan Authorized		 No
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