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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K041637
Device Name TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
Applicant
Envisioneering, LLC
1982 Innerbelt Business Ctr Dr.
St. Louis,  MO  63114
Applicant Contact TOM KAPPEL
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact SILVIA ANKOVA
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
FCG  
Date Received06/17/2004
Decision Date 09/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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