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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 K060631
Device Name BIOGRAPH 64 AND BIOGRAPH 40
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact ALAINE MEDIO
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received03/09/2006
Decision Date 03/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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