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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K971054
Device Name OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact JING ZHANG
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact JING ZHANG
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
KGI  
Date Received03/24/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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