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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 K861237
Device Name VASOVIEW DUPLEX IMAGING SYSTEM
Applicant
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Applicant Contact ROBERT D WASHAM
Correspondent
Sonicaid, Inc.
P.O. Box 588
Fredericksburg,  VA  22401
Correspondent Contact ROBERT D WASHAM
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/02/1986
Decision Date 07/14/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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