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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test-Pattern, Radiographic
510(k) Number K851812
Device Name DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.1940
Classification Product Code
IXF  
Date Received04/26/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
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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