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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K894412
Device Name RADIOSCOPE OR MAMMOSCOPE
Applicant
Vision Ten, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact PATRICK DUNN
Correspondent
Vision Ten, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact PATRICK DUNN
Regulation Number892.2030
Classification Product Code
LMA  
Date Received07/17/1989
Decision Date 12/22/1989
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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