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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K915362
Device Name VORTECH'S FILM DIGITIZER, FD-1
Applicant
Vortech Data, Inc.
2929 N. Central Expy.
Suite 101
Richardson,  TX  75080
Applicant Contact MANAGER, QA
Correspondent
Vortech Data, Inc.
2929 N. Central Expy.
Suite 101
Richardson,  TX  75080
Correspondent Contact MANAGER, QA
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/27/1991
Decision Date 04/06/1992
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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