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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 K922080
Device Name GENESYS II
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact PAUL VICHA
Correspondent
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Correspondent Contact PAUL VICHA
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/04/1992
Decision Date 07/17/1992
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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