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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 K080555
Device Name SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Applicant
Ivu Imaging Corporation
4121 Grace Ln.
Grapevine,  TX  76051
Applicant Contact MARK L STRIBLING
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYO  
Date Received02/28/2008
Decision Date 06/03/2008
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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