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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 K892875
Device Name BIAD NUCLEAR IMAGING SYSTEM
Applicant
Trionix Research Laboratory, Inc.
80037 Bavaria Rd.
Twinsburg,  OH  44087
Applicant Contact LIM, PH.D.
Correspondent
Trionix Research Laboratory, Inc.
80037 Bavaria Rd.
Twinsburg,  OH  44087
Correspondent Contact LIM, PH.D.
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/19/1989
Decision Date 07/20/1989
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
Recalls CDRH Recalls
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