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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, tomography, computed
510(k) Number K913491
Device Name VORTECH'S PERSONAL DISPLAY SYSTEM
Applicant
VORTECH DATA, INC.
2929 NORTH CENTRAL EXPRESSWAY
SUITE 101
richardson,  TX  75080
Applicant Contact douglas l sprague
Correspondent
VORTECH DATA, INC.
2929 NORTH CENTRAL EXPRESSWAY
SUITE 101
richardson,  TX  75080
Correspondent Contact douglas l sprague
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/06/1991
Decision Date 09/06/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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