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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, Fluoroscopic, Image-Intensified
510(k) Number K912896
Device Name DIGISTORE 2100
Applicant
Enhanced Imaging Technologies, Inc.
625 Alaska Ave.
Torrance,  CA  90503
Applicant Contact RICHARD L ADAMEK
Correspondent
Enhanced Imaging Technologies, Inc.
625 Alaska Ave.
Torrance,  CA  90503
Correspondent Contact RICHARD L ADAMEK
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/01/1991
Decision Date 08/26/1991
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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