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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 K873775
Device Name TRIAD NUCLEAR IMAGING SYSTEM
Applicant
Trionix Research Laboratory, Inc.
80037 Bavaria Rd.
Twinsburg,  OH  44087
Applicant Contact LIM, PHD
Correspondent
Trionix Research Laboratory, Inc.
80037 Bavaria Rd.
Twinsburg,  OH  44087
Correspondent Contact LIM, PHD
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/16/1987
Decision Date 01/19/1988
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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