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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K935498
Device Name 7500 DATA TOWER
Applicant
E-Systems, Inc.
P.O. Box 660023
1200 Jupiter Rd.
Dallas,  TX  75266
Applicant Contact S. R. RAIT
Correspondent
E-Systems, Inc.
P.O. Box 660023
1200 Jupiter Rd.
Dallas,  TX  75266
Correspondent Contact S. R. RAIT
Regulation Number892.2010
Classification Product Code
LMB  
Date Received11/16/1993
Decision Date 04/01/1994
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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