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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 K943156
Device Name SYSTEM, IMAGE PROCESSING
Applicant
Image Technology, Inc.
2999 Overland Ave. #204
Los Angeles,  CA  90064
Applicant Contact DAN RILEY
Correspondent
Image Technology, Inc.
2999 Overland Ave. #204
Los Angeles,  CA  90064
Correspondent Contact DAN RILEY
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/30/1994
Decision Date 05/04/1995
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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