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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 K071513
Device Name INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Applicant
Siemens Medical Solutions
Siemensstrasse 1
Forchheim,  DE D-91301
Applicant Contact RALF HOFMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/04/2007
Decision Date 06/26/2007
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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