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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 K032475
Device Name SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact NEALIE HARTMAN
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact NEALIE HARTMAN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/12/2003
Decision Date 11/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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