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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K925964
Device Name IMAGE TRANSPORT SERIES III
Applicant
Dataview Imaging Intl., Inc.
Sixth Floor
1001 Pennsylvania Ave. NW
Washington,  DC  20004
Applicant Contact VON OEHSEN
Correspondent
Dataview Imaging Intl., Inc.
Sixth Floor
1001 Pennsylvania Ave. NW
Washington,  DC  20004
Correspondent Contact VON OEHSEN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/25/1992
Decision Date 02/03/1995
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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