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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K962955
Device Name GAMMACON IMAGE TRANSLATION SYSTEM
Applicant
Medical Imaging Technology Assoc., Inc.
29 Main St.
P.O. Box 197
Mainland,  PA  19451
Applicant Contact PETER F HECKMAN
Correspondent
Medical Imaging Technology Assoc., Inc.
29 Main St.
P.O. Box 197
Mainland,  PA  19451
Correspondent Contact PETER F HECKMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/30/1996
Decision Date 10/28/1996
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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