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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K091373
Device Name SYNGO TRUED
Applicant
Siemens Medical Solutions USA, Inc.
20 Valley Stream Pkwy.
Malvern,  PA  19355
Applicant Contact JAMES E KUHN JR
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/11/2009
Decision Date 05/20/2009
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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