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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K931376
Device Name GAMMACON IMAGE TRANSLATION SYSTEM
Applicant
Numa Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JAMES VEALE
Correspondent
Numa Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES VEALE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/16/1993
Decision Date 07/28/1993
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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