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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 K884434
Device Name VORTECH'S MEDICAL IMAGING GATEWAY
Applicant
Vortech Data, Inc.
1891 Preston White Dr.,
Suite 200
Reston,  VA  22091
Applicant Contact GITLIN, DPH
Correspondent
Vortech Data, Inc.
1891 Preston White Dr.,
Suite 200
Reston,  VA  22091
Correspondent Contact GITLIN, DPH
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/20/1988
Decision Date 01/19/1989
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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